RE-DEEM Dose Finding Study for Dabigatran Etexilate in Patients With Acute Coronary Syndrome
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT00621855
Collaborator
Uppsala University (Other)
1,878
167
5
11.2
Study Details
Study Description
Brief Summary
The purpose of this trial is to evaluate the safety and indicators of efficacy of up to 4 doses of orally administered dabigatran etexilate, administered twice daily, compared to placebo when given in addition to dual antiplatelet treatment in patients with an index event (MI) at high risk for new ischaemic cardiovascular events.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1878 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
RandomizEd Dabigatran Etexilate Dose Finding Study in Patients With Acute Coronary Syndromes Post Index Event With Additional Risk Factors for Cardiovascular Complications Also Receiving Aspirin and Clopidogrel: Multi-centre, Prospective, Placebo Controlled, Cohort Dose Escalation Study (RE-DEEM)
Study Start Date
:
Mar 1, 2008
Actual Primary Completion Date
:
Oct 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dabigatran etexilate 50mg twice daily dosing, |
Drug: dabigatran etexilate
capsules, twice daily, 26 weeks treatment
|
| Experimental: Dabigatran etexilate 75mg twice daily dosing, patients with moderate renal impairment allocated 50mg bid |
Drug: dabigatran etexilate
capsules, twice daily, 26 weeks treatment
|
| Experimental: Dabigatran etexilate 110mg twice daily dosing, patients with moderate renal impairment allocated 75mg bid |
Drug: dabigatran etexilate
capsules, twice daily, 26 weeks treatment
|
| Experimental: dabigatran etexilate 150mg twice daily dosing, patients with moderate renal impairment allocated 110mg bid |
Drug: dabigatran etexilate
capsules, twice daily, 26 weeks treatment
|
| Placebo Comparator: placebo matched placebo |
Drug: placebo
matched placebo
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Displaying the Composite of Major and Clinically Relevant Minor Bleeding Events During Total Observation Time [6 month treatment period + 2 week post treatment follow up]
International Society Thrombosis and Haemostasis (ISTH) definition of a major bleed, and clinically relevant minor bleed. A bleeding event was considered as major if it was fatal, was a symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome), or caused a fall in haemoglobin level of ≥2 g/dL (≥1.24 mmol/L), or led to transfusion of ≥2 units of whole blood or red cells. All non major bleeding events were classified as minor bleeds; minor bleeds were subdivided in clinically relevant minor bleeds and not clinically relevant minor bleeds. A CRBE was defined as an acute or subacute clinically overt bleed that did not meet the criteria of a major bleed but either lead to hospital admission and/or a physician guided medical or surgical treatment and/or a change in antithrombotic therapy (including interruption or discontinuation of study drug).
Secondary Outcome Measures
- Composite of Cardiovascular Death (CVD) With Non Fatal Myocardial Infarction (MI) and Non Haemorrhagic Stroke and All Cause Death (ACD), Non Fatal MI, Severe Recurrent Ischaemia (SRI) and Non Haemorrhagic Stroke During Six Months Treatment [6 month treatment period + 2 week post treatment follow up]
Number of Participants with Composite of Cardiovascular death (CVD) with non fatal myocardial infarction (MI) and non haemorrhagic stroke and All cause death (ACD), non fatal MI, severe recurrent ischaemia (SRI) and non haemorrhagic stroke during six months treatment
- Individual Occurrence of Death (Cardiovascular and All-cause), Non-fatal MI, Severe Recurrent Ischaemia and Non-haemorrhagic Stroke During Six Months of Treatment [6 month treatment period + 2 week post treatment follow up]
Number of Participants with individual occurrence of death (cardiovascular and all-cause), non-fatal MI, severe recurrent ischaemia and non-haemorrhagic stroke during six months of treatment.
- Number of Participants With Any Reduction of D-dimer Concentration [at 1 week and 4 weeks]
- Change From Baseline in log10 D-dimer After 1 and 4 Weeks [Baseline and at 1 week and 4 weeks]
Change from baseline in log10 D-dimer concentration after 1 and 4 weeks of dabigatran etexilate treatment compared to placebo. The standard deviation is the geometric standard deviation.
- Number of Participants With Bleeding Events During Total Observation Time [6 month treatment period + 2 week post treatment follow up]
International Society Thrombosis and Haemostasis (ISTH) definition of a major bleed, and clinically relevant minor bleed. A bleeding event was considered as major if it was fatal, was a symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome), or caused a fall in haemoglobin level of ≥2 g/dL (≥1.24 mmol/L), or led to transfusion of ≥2 units of whole blood or red cells. All non major bleeding events were classified as minor bleeds; minor bleeds were subdivided in clinically relevant minor bleeds (CRBE) and not clinically relevant minor bleeds. A CRBE was defined as an acute or subacute clinically overt bleed that did not meet the criteria of a major bleed but either lead to hospital admission and/or a physician guided medical or surgical treatment and/or a change in antithrombotic therapy (including interruption or discontinuation of study drug).
- Laboratory Analyses [6 month treatment period + 2 week post treatment follow up]
Number of patients with possible clinically significant abnormalities. Clinically significant abnormalities refers to the increase or decrease from baseline.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria Patients with acute coronary syndromes with at least one additional risk factor for cardiovascular complications.
Exclusion criteria
-
Long term treatment with any other oral anticoagulant
-
Severe/disabling stroke within last 6 months
-
Conditions associated with increased bleeding risk
-
Anaemia or thrombocytopenia
-
Severe renal impairment
-
Liver disease
-
Positive pregnancy test
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 1160.67.10002 Boehringer Ingelheim Investigational Site | Clearwater | Florida | United States | |
| 2 | 1160.67.32008 Boehringer Ingelheim Investigational Site | Bouge/Namur | Belgium | ||
| 3 | 1160.67.32011 Boehringer Ingelheim Investigational Site | Brasschaat | Belgium | ||
| 4 | 1160.67.32005 Boehringer Ingelheim Investigational Site | Edegem | Belgium | ||
| 5 | 1160.67.32002 Boehringer Ingelheim Investigational Site | Genk | Belgium | ||
| 6 | 1160.67.32006 Boehringer Ingelheim Investigational Site | Gilly | Belgium | ||
| 7 | 1160.67.32003 Boehringer Ingelheim Investigational Site | Hasselt | Belgium | ||
| 8 | 1160.67.32001 Boehringer Ingelheim Investigational Site | Leuven | Belgium | ||
| 9 | 1160.67.32004 Boehringer Ingelheim Investigational Site | Tienen | Belgium | ||
| 10 | 1160.67.59007 Boehringer Ingelheim Investigational Site | Bourgas | Bulgaria | ||
| 11 | 1160.67.59009 Boehringer Ingelheim Investigational Site | Dimitrovgrad | Bulgaria | ||
| 12 | 1160.67.59003 Boehringer Ingelheim Investigational Site | Pleven | Bulgaria | ||
| 13 | 1160.67.59012 Boehringer Ingelheim Investigational Site | Pleven | Bulgaria | ||
| 14 | 1160.67.59006 Boehringer Ingelheim Investigational Site | Rousse | Bulgaria | ||
| 15 | 1160.67.59001 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria | ||
| 16 | 1160.67.59002 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria | ||
| 17 | 1160.67.59004 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria | ||
| 18 | 1160.67.59005 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria | ||
| 19 | 1160.67.59008 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria | ||
| 20 | 1160.67.59010 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria | ||
| 21 | 1160.67.11009 Boehringer Ingelheim Investigational Site | Calgary | Alberta | Canada | |
| 22 | 1160.67.11003 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia | Canada | |
| 23 | 1160.67.11012 Boehringer Ingelheim Investigational Site | Cambridge | Ontario | Canada | |
| 24 | 1160.67.11008 Boehringer Ingelheim Investigational Site | Hamilton | Ontario | Canada | |
| 25 | 1160.67.11018 Boehringer Ingelheim Investigational Site | London | Ontario | Canada | |
| 26 | 1160.67.11017 Boehringer Ingelheim Investigational Site | Mississauga | Ontario | Canada | |
| 27 | 1160.67.11010 Boehringer Ingelheim Investigational Site | Sudbury | Ontario | Canada | |
| 28 | 1160.67.11020 Boehringer Ingelheim Investigational Site | Sudbury | Ontario | Canada | |
| 29 | 1160.67.11004 Boehringer Ingelheim Investigational Site | Montreal | Quebec | Canada | |
| 30 | 1160.67.11016 Boehringer Ingelheim Investigational Site | Montreal | Quebec | Canada | |
| 31 | 1160.67.11006 Boehringer Ingelheim Investigational Site | Terrebonne | Quebec | Canada | |
| 32 | 1160.67.11014 Boehringer Ingelheim Investigational Site | Quebec | Canada | ||
| 33 | 1160.67.42007 Boehringer Ingelheim Investigational Site | Hradec Kralove | Czech Republic | ||
| 34 | 1160.67.42005 Boehringer Ingelheim Investigational Site | Litomerice | Czech Republic | ||
| 35 | 1160.67.42008 Boehringer Ingelheim Investigational Site | Ostrava | Czech Republic | ||
| 36 | 1160.67.42001 Boehringer Ingelheim Investigational Site | Prague | Czech Republic | ||
| 37 | 1160.67.42003 Boehringer Ingelheim Investigational Site | Teplice | Czech Republic | ||
| 38 | 1160.67.42002 Boehringer Ingelheim Investigational Site | Zlin | Czech Republic | ||
| 39 | 1160.67.45001 Boehringer Ingelheim Investigational Site | Aarhus C | Denmark | ||
| 40 | 1160.67.45003 Boehringer Ingelheim Investigational Site | Hvidovre | Denmark | ||
| 41 | 1160.67.45002 Boehringer Ingelheim Investigational Site | Odense | Denmark | ||
| 42 | 1160.67.45004 Boehringer Ingelheim Investigational Site | Roskilde | Denmark | ||
| 43 | 1160.67.58001 Boehringer Ingelheim Investigational Site | HUS | Finland | ||
| 44 | 1160.67.58004 Boehringer Ingelheim Investigational Site | Jyväskylä | Finland | ||
| 45 | 1160.67.58003 Boehringer Ingelheim Investigational Site | Kuopio | Finland | ||
| 46 | 1160.67.58002 Boehringer Ingelheim Investigational Site | Pori | Finland | ||
| 47 | 1160.67.3305A Boehringer Ingelheim Investigational Site | Brest Cedex | France | ||
| 48 | 1160.67.3305B Boehringer Ingelheim Investigational Site | Brest Cedex | France | ||
| 49 | 1160.67.3303A Boehringer Ingelheim Investigational Site | Dijon Cedex | France | ||
| 50 | 1160.67.3303B Boehringer Ingelheim Investigational Site | Dijon Cedex | France | ||
| 51 | 1160.67.3303C Boehringer Ingelheim Investigational Site | Dijon Cedex | France | ||
| 52 | 1160.67.3303D Boehringer Ingelheim Investigational Site | Dijon Cedex | France | ||
| 53 | 1160.67.3301A Boehringer Ingelheim Investigational Site | Paris | France | ||
| 54 | 1160.67.95001 Boehringer Ingelheim Investigational Site | Tbilisi | Georgia | ||
| 55 | 1160.67.95002 Boehringer Ingelheim Investigational Site | Tbilisi | Georgia | ||
| 56 | 1160.67.95003 Boehringer Ingelheim Investigational Site | Tbilisi | Georgia | ||
| 57 | 1160.67.95004 Boehringer Ingelheim Investigational Site | Tbilisi | Georgia | ||
| 58 | 1160.67.95005 Boehringer Ingelheim Investigational Site | Tbilisi | Georgia | ||
| 59 | 1160.67.95006 Boehringer Ingelheim Investigational Site | Tbilisi | Georgia | ||
| 60 | 1160.67.49001 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 61 | 1160.67.49007 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 62 | 1160.67.49017 Boehringer Ingelheim Investigational Site | Dresden | Germany | ||
| 63 | 1160.67.49006 Boehringer Ingelheim Investigational Site | Hannover | Germany | ||
| 64 | 1160.67.49019 Boehringer Ingelheim Investigational Site | Homburg/Saar | Germany | ||
| 65 | 1160.67.49008 Boehringer Ingelheim Investigational Site | Ludwigshafen am Rhein | Germany | ||
| 66 | 1160.67.49015 Boehringer Ingelheim Investigational Site | Neuss | Germany | ||
| 67 | 1160.67.49004 Boehringer Ingelheim Investigational Site | Rostock | Germany | ||
| 68 | 1160.67.36001 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 69 | 1160.67.36003 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 70 | 1160.67.36004 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 71 | 1160.67.36002 Boehringer Ingelheim Investigational Site | Debrecen | Hungary | ||
| 72 | 1160.67.36007 Boehringer Ingelheim Investigational Site | Kecskemet | Hungary | ||
| 73 | 1160.67.36006 Boehringer Ingelheim Investigational Site | Komarom | Hungary | ||
| 74 | 1160.67.36008 Boehringer Ingelheim Investigational Site | Miskolc | Hungary | ||
| 75 | 1160.67.36009 Boehringer Ingelheim Investigational Site | Mosonmagyarovar | Hungary | ||
| 76 | 1160.67.36005 Boehringer Ingelheim Investigational Site | Zalaegerszeg | Hungary | ||
| 77 | 1160.67.91004 Boehringer Ingelheim Investigational Site | Amedabad | India | ||
| 78 | 1160.67.91001 Boehringer Ingelheim Investigational Site | Chennai | India | ||
| 79 | 1160.67.91005 Boehringer Ingelheim Investigational Site | Hyderabad | India | ||
| 80 | 1160.67.91007 Boehringer Ingelheim Investigational Site | Lucknow | India | ||
| 81 | 1160.67.91002 Boehringer Ingelheim Investigational Site | Mumbai | India | ||
| 82 | 1160.67.91003 Boehringer Ingelheim Investigational Site | Pune | India | ||
| 83 | 1160.67.91006 Boehringer Ingelheim Investigational Site | Pune | India | ||
| 84 | 1160.67.53001 Boehringer Ingelheim Investigational Site | Dublin | Ireland | ||
| 85 | 1160.67.53002 Boehringer Ingelheim Investigational Site | Dublin | Ireland | ||
| 86 | 1160.67.39006 Boehringer Ingelheim Investigational Site | Ascoli Piceno | Italy | ||
| 87 | 1160.67.39003 Boehringer Ingelheim Investigational Site | Milano | Italy | ||
| 88 | 1160.67.39005 Boehringer Ingelheim Investigational Site | Milano | Italy | ||
| 89 | 1160.67.39001 Boehringer Ingelheim Investigational Site | Parma | Italy | ||
| 90 | 1160.67.39002 Boehringer Ingelheim Investigational Site | S. Maria Capua Vetere (CE) | Italy | ||
| 91 | 1160.67.39004 Boehringer Ingelheim Investigational Site | Torino | Italy | ||
| 92 | 1160.67.82010 Boehringer Ingelheim Investigational Site | Busan | Korea, Republic of | ||
| 93 | 1160.67.82008 Boehringer Ingelheim Investigational Site | Daegu | Korea, Republic of | ||
| 94 | 1160.67.82009 Boehringer Ingelheim Investigational Site | Daegu | Korea, Republic of | ||
| 95 | 1160.67.82013 Boehringer Ingelheim Investigational Site | Daejeon | Korea, Republic of | ||
| 96 | 1160.67.82006 Boehringer Ingelheim Investigational Site | Daejoen | Korea, Republic of | ||
| 97 | 1160.67.82007 Boehringer Ingelheim Investigational Site | Incheon | Korea, Republic of | ||
| 98 | 1160.67.82012 Boehringer Ingelheim Investigational Site | Jeonju | Korea, Republic of | ||
| 99 | 1160.67.82005 Boehringer Ingelheim Investigational Site | Kwang-Ju | Korea, Republic of | ||
| 100 | 1160.67.82011 Boehringer Ingelheim Investigational Site | Pusan | Korea, Republic of | ||
| 101 | 1160.67.82001 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 102 | 1160.67.82002 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 103 | 1160.67.82003 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 104 | 1160.67.82004 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 105 | 1160.67.31001 Boehringer Ingelheim Investigational Site | Amsterdam | Netherlands | ||
| 106 | 1160.67.31003 Boehringer Ingelheim Investigational Site | Den Bosch | Netherlands | ||
| 107 | 1160.67.31007 Boehringer Ingelheim Investigational Site | Den Haag | Netherlands | ||
| 108 | 1160.67.31009 Boehringer Ingelheim Investigational Site | Ede | Netherlands | ||
| 109 | 1160.67.31002 Boehringer Ingelheim Investigational Site | Groningen | Netherlands | ||
| 110 | 1160.67.31006 Boehringer Ingelheim Investigational Site | Helmond | Netherlands | ||
| 111 | 1160.67.31011 Boehringer Ingelheim Investigational Site | Hoogeveen | Netherlands | ||
| 112 | 1160.67.31005 Boehringer Ingelheim Investigational Site | Rotterdam | Netherlands | ||
| 113 | 1160.67.31008 Boehringer Ingelheim Investigational Site | Spijkenisse | Netherlands | ||
| 114 | 1160.67.31004 Boehringer Ingelheim Investigational Site | Tilburg | Netherlands | ||
| 115 | 1160.67.47005 Boehringer Ingelheim Investigational Site | Drammen | Norway | ||
| 116 | 1160.67.47002 Boehringer Ingelheim Investigational Site | Hamar | Norway | ||
| 117 | 1160.67.47003 Boehringer Ingelheim Investigational Site | Haugesund | Norway | ||
| 118 | 1160.67.47004 Boehringer Ingelheim Investigational Site | Hønefoss | Norway | ||
| 119 | 1160.67.47001 Boehringer Ingelheim Investigational Site | Oslo | Norway | ||
| 120 | 1160.67.48003 Boehringer Ingelheim Investigational Site | Bydgoszcz | Poland | ||
| 121 | 1160.67.48006 Boehringer Ingelheim Investigational Site | Bydgoszcz | Poland | ||
| 122 | 1160.67.48004 Boehringer Ingelheim Investigational Site | Gdynia | Poland | ||
| 123 | 1160.67.48005 Boehringer Ingelheim Investigational Site | Inowroclaw | Poland | ||
| 124 | 1160.67.48002 Boehringer Ingelheim Investigational Site | Sopot | Poland | ||
| 125 | 1160.67.48001 Boehringer Ingelheim Investigational Site | Warsaw | Poland | ||
| 126 | 1160.67.40006 Boehringer Ingelheim Investigational Site | Baia Mare | Romania | ||
| 127 | 1160.67.40005 Boehringer Ingelheim Investigational Site | Braila | Romania | ||
| 128 | 1160.67.40001 Boehringer Ingelheim Investigational Site | Bucharest | Romania | ||
| 129 | 1160.67.40003 Boehringer Ingelheim Investigational Site | Bucharest | Romania | ||
| 130 | 1160.67.40004 Boehringer Ingelheim Investigational Site | Bucharest | Romania | ||
| 131 | 1160.67.40002 Boehringer Ingelheim Investigational Site | Oradea | Romania | ||
| 132 | 1160.67.40007 Boehringer Ingelheim Investigational Site | Tg. Mures | Romania | ||
| 133 | 1160.67.70001 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 134 | 1160.67.70002 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 135 | 1160.67.70003 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 136 | 1160.67.70004 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 137 | 1160.67.70005 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 138 | 1160.67.70006 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 139 | 1160.67.70007 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 140 | 1160.67.70010 Boehringer Ingelheim Investigational Site | Saratov | Russian Federation | ||
| 141 | 1160.67.70011 Boehringer Ingelheim Investigational Site | Saratov | Russian Federation | ||
| 142 | 1160.67.70008 Boehringer Ingelheim Investigational Site | St. Petersburg | Russian Federation | ||
| 143 | 1160.67.70009 Boehringer Ingelheim Investigational Site | St. Petersburg | Russian Federation | ||
| 144 | 1160.67.34001 Boehringer Ingelheim Investigational Site | Barcelona | Spain | ||
| 145 | 1160.67.34002 Boehringer Ingelheim Investigational Site | Barcelona | Spain | ||
| 146 | 1160.67.34005 Boehringer Ingelheim Investigational Site | Madrid | Spain | ||
| 147 | 1160.67.34006 Boehringer Ingelheim Investigational Site | Madrid | Spain | ||
| 148 | 1160.67.34003 Boehringer Ingelheim Investigational Site | Sabadell (Barcelona) | Spain | ||
| 149 | 1160.67.34004 Boehringer Ingelheim Investigational Site | Tarragona | Spain | ||
| 150 | 1160.67.46004 Boehringer Ingelheim Investigational Site | Göteborg | Sweden | ||
| 151 | 1160.67.46006 Boehringer Ingelheim Investigational Site | Göteborg | Sweden | ||
| 152 | 1160.67.46007 Boehringer Ingelheim Investigational Site | Malmö | Sweden | ||
| 153 | 1160.67.46005 Boehringer Ingelheim Investigational Site | Motala | Sweden | ||
| 154 | 1160.67.46002 Boehringer Ingelheim Investigational Site | Stockholm | Sweden | ||
| 155 | 1160.67.46001 Boehringer Ingelheim Investigational Site | Uppsala | Sweden | ||
| 156 | 1160.67.46003 Boehringer Ingelheim Investigational Site | Vaesteraas | Sweden | ||
| 157 | 1160.67.38002 Boehringer Ingelheim Investigational Site | Ivano-Frankovsk | Ukraine | ||
| 158 | 1160.67.38004 Boehringer Ingelheim Investigational Site | Kharkov | Ukraine | ||
| 159 | 1160.67.38007 Boehringer Ingelheim Investigational Site | Kharkov | Ukraine | ||
| 160 | 1160.67.38001 Boehringer Ingelheim Investigational Site | Kiev | Ukraine | ||
| 161 | 1160.67.38003 Boehringer Ingelheim Investigational Site | Kiev | Ukraine | ||
| 162 | 1160.67.38005 Boehringer Ingelheim Investigational Site | Kiev | Ukraine | ||
| 163 | 1160.67.38008 Boehringer Ingelheim Investigational Site | Nikolayev | Ukraine | ||
| 164 | 1160.67.38006 Boehringer Ingelheim Investigational Site | Odessa | Ukraine | ||
| 165 | 1160.67.44003 Boehringer Ingelheim Investigational Site | Brighton | United Kingdom | ||
| 166 | 1160.67.44002 Boehringer Ingelheim Investigational Site | Exeter | United Kingdom | ||
| 167 | 1160.67.44001 Boehringer Ingelheim Investigational Site | Middlesbrough | United Kingdom |
Sponsors and Collaborators
- Boehringer Ingelheim
- Uppsala University
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00621855
Other Study ID Numbers:
- 1160.67
- RE-DEEM
- 2007-004301-99
First Posted:
Feb 22, 2008
Last Update Posted:
Mar 12, 2014
Last Verified:
Feb 1, 2014
Study Results
Participant Flow
| Recruitment Details | International multi-centre trial with 161 trial sites in 24 countries recruiting patients with acute coronary syndromes with increased troponin levels within 14 days post index myocardial infarction (ST or non-ST elevation between March 2008 and March 2009. |
|---|---|
| Pre-assignment Detail | Patients receiving aspirin and clopidogrel at randomisation were included. They also had at least 1 additional risk factor (for e.g. age ≥65 years, diabetes previous myocardial infarction, peripheral arterial disease). Moderate renal impairment at screening resulted in dose adjustment. |
| Arm/Group Title | 50mg Dabigatran Etexilate | 75mg Dabigatran Etexilate | 110mg Dabigatran Etexilate | 150mg Dabigatran Etexilate | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment |
| Period Title: Overall Study | |||||
| STARTED | 372 | 371 | 411 | 351 | 373 |
| COMPLETED | 296 | 310 | 330 | 284 | 318 |
| NOT COMPLETED | 76 | 61 | 81 | 67 | 55 |
Baseline Characteristics
| Arm/Group Title | 50mg Dabigatran Etexilate | 75mg Dabigatran Etexilate | 110mg Dabigatran Etexilate | 150mg Dabigatran Etexilate | Placebo | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment | Total of all reporting groups |
| Overall Participants | 372 | 371 | 411 | 351 | 373 | 1878 |
| Age (Years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [Years] |
61.9
(12.2)
|
60.7
(11.7)
|
62.3
(11.1)
|
62.3
(10.8)
|
61.5
(11.3)
|
61.8
(11.4)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
84
22.6%
|
75
20.2%
|
117
28.5%
|
93
26.5%
|
81
21.7%
|
450
24%
|
| Male |
288
77.4%
|
296
79.8%
|
294
71.5%
|
258
73.5%
|
292
78.3%
|
1428
76%
|
| Race (NIH/OMB) (participants) [Number] | ||||||
| White |
288
77.4%
|
267
72%
|
324
78.8%
|
300
85.5%
|
268
71.8%
|
1447
77.1%
|
| Black |
0
0%
|
1
0.3%
|
0
0%
|
0
0%
|
0
0%
|
1
0.1%
|
| Asian |
84
22.6%
|
102
27.5%
|
82
20%
|
51
14.5%
|
105
28.2%
|
424
22.6%
|
| Other |
0
0%
|
1
0.3%
|
5
1.2%
|
0
0%
|
0
0%
|
6
0.3%
|
| Region of Enrollment (participants) [Number] | ||||||
| Central Europe |
165
44.4%
|
155
41.8%
|
230
56%
|
217
61.8%
|
165
44.2%
|
932
49.6%
|
| Western Europe |
98
26.3%
|
93
25.1%
|
79
19.2%
|
72
20.5%
|
84
22.5%
|
426
22.7%
|
| Asia |
84
22.6%
|
99
26.7%
|
81
19.7%
|
51
14.5%
|
104
27.9%
|
419
22.3%
|
| North America |
25
6.7%
|
24
6.5%
|
21
5.1%
|
11
3.1%
|
20
5.4%
|
101
5.4%
|
| Type of Index Event (participants) [Number] | ||||||
| ST elevation myocardial infarction (STEMI) |
211
56.7%
|
227
61.2%
|
254
61.8%
|
204
58.1%
|
230
61.7%
|
1126
60%
|
| Non ST elevation myocardial infarction (NSTEMI) |
161
43.3%
|
144
38.8%
|
157
38.2%
|
147
41.9%
|
143
38.3%
|
752
40%
|
| Creatinine Clearance N=(372;371;411;350;373;1877) (mL/min) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [mL/min] |
85.4
(30.2)
|
88.7
(32.4)
|
84.7
(32)
|
86.3
(28.1)
|
86.6
(34.8)
|
86.3
(31.6)
|
Outcome Measures
| Title | Number of Participants Displaying the Composite of Major and Clinically Relevant Minor Bleeding Events During Total Observation Time |
|---|---|
| Description | International Society Thrombosis and Haemostasis (ISTH) definition of a major bleed, and clinically relevant minor bleed. A bleeding event was considered as major if it was fatal, was a symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome), or caused a fall in haemoglobin level of ≥2 g/dL (≥1.24 mmol/L), or led to transfusion of ≥2 units of whole blood or red cells. All non major bleeding events were classified as minor bleeds; minor bleeds were subdivided in clinically relevant minor bleeds and not clinically relevant minor bleeds. A CRBE was defined as an acute or subacute clinically overt bleed that did not meet the criteria of a major bleed but either lead to hospital admission and/or a physician guided medical or surgical treatment and/or a change in antithrombotic therapy (including interruption or discontinuation of study drug). |
| Time Frame | 6 month treatment period + 2 week post treatment follow up |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated set - The treated set includes all patients who received at least one dose of study medication. |
| Arm/Group Title | 50mg Dabigatran Etexilate | 75mg Dabigatran Etexilate | 110mg Dabigatran Etexilate | 150mg Dabigatran Etexilate | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment |
| Measure Participants | 369 | 368 | 406 | 347 | 371 |
| Major and clinically relevant minor bleed events |
13
3.5%
|
16
4.3%
|
32
7.8%
|
27
7.7%
|
8
2.1%
|
| No major or clinically relevant minor bleed events |
356
95.7%
|
352
94.9%
|
374
91%
|
320
91.2%
|
363
97.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 50mg Dabigatran Etexilate, 75mg Dabigatran Etexilate, 110mg Dabigatran Etexilate, 150mg Dabigatran Etexilate, Placebo |
|---|---|---|
| Comments | The proportion of patients who reach this endpoint were analysed by a logistic model for linear trend (dose response). The null hypothesis is that the relationship between dose level (0mg, 50mg, 75mg, 110mg and 150mg) and the proportions of patients with major and clinically relevant minor bleeding is not linear (slope parameter = 0) | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Cochran-Armitage test for linear trend | |
| Comments | ||
| Title | Composite of Cardiovascular Death (CVD) With Non Fatal Myocardial Infarction (MI) and Non Haemorrhagic Stroke and All Cause Death (ACD), Non Fatal MI, Severe Recurrent Ischaemia (SRI) and Non Haemorrhagic Stroke During Six Months Treatment |
|---|---|
| Description | Number of Participants with Composite of Cardiovascular death (CVD) with non fatal myocardial infarction (MI) and non haemorrhagic stroke and All cause death (ACD), non fatal MI, severe recurrent ischaemia (SRI) and non haemorrhagic stroke during six months treatment |
| Time Frame | 6 month treatment period + 2 week post treatment follow up |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated set |
| Arm/Group Title | 50mg Dabigatran Etexilate | 75mg Dabigatran Etexilate | 110mg Dabigatran Etexilate | 150mg Dabigatran Etexilate | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment |
| Measure Participants | 369 | 368 | 406 | 347 | 371 |
| CVD, non-fatal MI, non-haemorrhagic stroke |
17
4.6%
|
18
4.9%
|
12
2.9%
|
12
3.4%
|
14
3.8%
|
| ACD, non-fatal MI, SRI, non-haemorrhagic stroke |
25
6.7%
|
27
7.3%
|
21
5.1%
|
25
7.1%
|
26
7%
|
| Title | Individual Occurrence of Death (Cardiovascular and All-cause), Non-fatal MI, Severe Recurrent Ischaemia and Non-haemorrhagic Stroke During Six Months of Treatment |
|---|---|
| Description | Number of Participants with individual occurrence of death (cardiovascular and all-cause), non-fatal MI, severe recurrent ischaemia and non-haemorrhagic stroke during six months of treatment. |
| Time Frame | 6 month treatment period + 2 week post treatment follow up |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated set |
| Arm/Group Title | 50mg Dabigatran Etexilate | 75mg Dabigatran Etexilate | 110mg Dabigatran Etexilate | 150mg Dabigatran Etexilate | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment |
| Measure Participants | 369 | 368 | 406 | 347 | 371 |
| Cardiovascular death |
8
2.2%
|
9
2.4%
|
5
1.2%
|
4
1.1%
|
9
2.4%
|
| Non-fatal myocardial infarction |
9
2.4%
|
8
2.2%
|
7
1.7%
|
8
2.3%
|
4
1.1%
|
| Severe recurrent ischaemia |
9
2.4%
|
11
3%
|
9
2.2%
|
11
3.1%
|
9
2.4%
|
| Non-haemorrhagic stroke |
0
0%
|
1
0.3%
|
0
0%
|
0
0%
|
3
0.8%
|
| All cause death |
8
2.2%
|
10
2.7%
|
7
1.7%
|
7
2%
|
14
3.8%
|
| Title | Number of Participants With Any Reduction of D-dimer Concentration |
|---|---|
| Description | |
| Time Frame | at 1 week and 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set - The full analysis set includes all randomised and treated patients who had at least one post-dose assessment of D-dimer available. |
| Arm/Group Title | 50mg Dabigatran Etexilate | 75mg Dabigatran Etexilate | 110mg Dabigatran Etexilate | 150mg Dabigatran Etexilate | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment |
| Measure Participants | 358 | 358 | 388 | 332 | 356 |
| Number of Patients with any reduction |
290
78%
|
293
79%
|
333
81%
|
296
84.3%
|
264
70.8%
|
| Number of Patients with no reduction |
48
12.9%
|
49
13.2%
|
41
10%
|
28
8%
|
77
20.6%
|
| Missing data |
20
5.4%
|
16
4.3%
|
14
3.4%
|
8
2.3%
|
15
4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 50mg Dabigatran Etexilate, 75mg Dabigatran Etexilate, 110mg Dabigatran Etexilate, 150mg Dabigatran Etexilate, Placebo |
|---|---|---|
| Comments | The proportion of patients who reach this endpoint were analysed by a logistic model for linear trend (dose response). The null hypothesis is that the relationship between dose level (0mg, 50mg, 75mg, 110mg and 150mg) and the proportions of patients with major and clinically relevant minor bleeding is not linear (slope parameter = 0) | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Cochran-Armitage test for linear trend | |
| Comments | ||
| Title | Change From Baseline in log10 D-dimer After 1 and 4 Weeks |
|---|---|
| Description | Change from baseline in log10 D-dimer concentration after 1 and 4 weeks of dabigatran etexilate treatment compared to placebo. The standard deviation is the geometric standard deviation. |
| Time Frame | Baseline and at 1 week and 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) |
| Arm/Group Title | 50mg Dabigatran Etexilate | 75mg Dabigatran Etexilate | 110mg Dabigatran Etexilate | 150mg Dabigatran Etexilate | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment |
| Measure Participants | 358 | 358 | 388 | 332 | 356 |
| Ratio of week 4 to baseline |
0.33
(3.04)
|
0.31
(3.30)
|
0.29
(3.14)
|
0.31
(3.02)
|
0.57
(3.01)
|
| Ratio of week 1 to baseline |
0.58
(2.60)
|
0.52
(2.81)
|
0.52
(2.54)
|
0.55
(2.58)
|
0.87
(2.45)
|
| Title | Number of Participants With Bleeding Events During Total Observation Time |
|---|---|
| Description | International Society Thrombosis and Haemostasis (ISTH) definition of a major bleed, and clinically relevant minor bleed. A bleeding event was considered as major if it was fatal, was a symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome), or caused a fall in haemoglobin level of ≥2 g/dL (≥1.24 mmol/L), or led to transfusion of ≥2 units of whole blood or red cells. All non major bleeding events were classified as minor bleeds; minor bleeds were subdivided in clinically relevant minor bleeds (CRBE) and not clinically relevant minor bleeds. A CRBE was defined as an acute or subacute clinically overt bleed that did not meet the criteria of a major bleed but either lead to hospital admission and/or a physician guided medical or surgical treatment and/or a change in antithrombotic therapy (including interruption or discontinuation of study drug). |
| Time Frame | 6 month treatment period + 2 week post treatment follow up |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated set |
| Arm/Group Title | 50mg Dabigatran Etexilate | 75mg Dabigatran Etexilate | 110mg Dabigatran Etexilate | 150mg Dabigatran Etexilate | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment |
| Measure Participants | 369 | 368 | 406 | 347 | 371 |
| Major bleeding events |
3
0.8%
|
1
0.3%
|
8
1.9%
|
4
1.1%
|
2
0.5%
|
| Clinically relevant bleeding events |
10
2.7%
|
16
4.3%
|
24
5.8%
|
23
6.6%
|
6
1.6%
|
| Not clinically relevant bleeding events |
32
8.6%
|
29
7.8%
|
35
8.5%
|
20
5.7%
|
17
4.6%
|
| Any bleeding events |
42
11.3%
|
45
12.1%
|
60
14.6%
|
42
12%
|
25
6.7%
|
| Title | Laboratory Analyses |
|---|---|
| Description | Number of patients with possible clinically significant abnormalities. Clinically significant abnormalities refers to the increase or decrease from baseline. |
| Time Frame | 6 month treatment period + 2 week post treatment follow up |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated set |
| Arm/Group Title | 50mg Dabigatran Etexilate | 75mg Dabigatran Etexilate | 110mg Dabigatran Etexilate | 150mg Dabigatran Etexilate | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment |
| Measure Participants | 369 | 368 | 406 | 347 | 371 |
| AST increase N=(359;359;388;329;356) |
8
2.2%
|
5
1.3%
|
5
1.2%
|
2
0.6%
|
4
1.1%
|
| AST decrease N=(359;359;388;329;356) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| ALT increase N=(359;359;388;329;356) |
10
2.7%
|
4
1.1%
|
4
1%
|
7
2%
|
4
1.1%
|
| ALT decrease N=(359;359;388;329;356) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Bilirubin increase N=(359;360;388;329;355) |
1
0.3%
|
1
0.3%
|
2
0.5%
|
0
0%
|
0
0%
|
| Bilirubin decrease N=(359;360;388;329;355) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | 6 month treatment period + 3 days | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||
| Arm/Group Title | 50mg Dabigatran Etexilate | 75mg Dabigatran Etexilate | 110mg Dabigatran Etexilate | 150mg Dabigatran Etexilate | Placebo | |||||
| Arm/Group Description | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment | 26 week blinded treatment | |||||
All Cause Mortality |
||||||||||
| 50mg Dabigatran Etexilate | 75mg Dabigatran Etexilate | 110mg Dabigatran Etexilate | 150mg Dabigatran Etexilate | Placebo | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| 50mg Dabigatran Etexilate | 75mg Dabigatran Etexilate | 110mg Dabigatran Etexilate | 150mg Dabigatran Etexilate | Placebo | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 33/369 (8.9%) | 31/368 (8.4%) | 35/406 (8.6%) | 21/347 (6.1%) | 32/371 (8.6%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| anaemia | 0/369 (0%) | 0 | 1/368 (0.3%) | 1 | 0/406 (0%) | 0 | 1/347 (0.3%) | 1 | 1/371 (0.3%) | 1 |
| thrombocythaemia | 1/369 (0.3%) | 1 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| Cardiac disorders | ||||||||||
| angina pectoris | 1/369 (0.3%) | 1 | 4/368 (1.1%) | 5 | 3/406 (0.7%) | 3 | 2/347 (0.6%) | 2 | 5/371 (1.3%) | 5 |
| Unstable angina | 4/369 (1.1%) | 4 | 4/368 (1.1%) | 4 | 2/406 (0.5%) | 2 | 1/347 (0.3%) | 1 | 1/371 (0.3%) | 1 |
| cardiac failure | 2/369 (0.5%) | 2 | 0/368 (0%) | 0 | 2/406 (0.5%) | 2 | 0/347 (0%) | 0 | 1/371 (0.3%) | 1 |
| atrial fibrillation | 1/369 (0.3%) | 1 | 0/368 (0%) | 0 | 2/406 (0.5%) | 2 | 0/347 (0%) | 0 | 2/371 (0.5%) | 2 |
| bradycardia | 0/369 (0%) | 0 | 1/368 (0.3%) | 1 | 1/406 (0.2%) | 1 | 1/347 (0.3%) | 1 | 0/371 (0%) | 0 |
| acute cardiac failure | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 2/406 (0.5%) | 2 | 1/347 (0.3%) | 1 | 0/371 (0%) | 0 |
| coronary artery stenosis | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 2/406 (0.5%) | 2 | 1/347 (0.3%) | 1 | 0/371 (0%) | 0 |
| acute LV failure | 1/369 (0.3%) | 1 | 1/368 (0.3%) | 1 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| arteriosclerosis coronary artery | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 1/347 (0.3%) | 1 | 1/371 (0.3%) | 1 |
| atrial flutter | 1/369 (0.3%) | 1 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| 1st degree AV block | 0/369 (0%) | 0 | 1/368 (0.3%) | 1 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| congestive cardiac failure | 1/369 (0.3%) | 1 | 0/368 (0%) | 0 | 1/406 (0.2%) | 1 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| cardiac tamponade | 1/369 (0.3%) | 1 | 1/368 (0.3%) | 1 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| coronary artery disease | 1/369 (0.3%) | 1 | 1/368 (0.3%) | 1 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 2/371 (0.5%) | 2 |
| coronary artery occlusion | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 1/406 (0.2%) | 1 | 1/347 (0.3%) | 1 | 0/371 (0%) | 0 |
| coronary artery thrombosis | 1/369 (0.3%) | 1 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| LV failure | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 1/406 (0.2%) | 1 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| myocardial infarction | 1/369 (0.3%) | 1 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| myocardial ischaemia | 1/369 (0.3%) | 1 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 1/371 (0.3%) | 1 |
| post infarct angina | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 1/406 (0.2%) | 1 | 0/347 (0%) | 0 | 1/371 (0.3%) | 1 |
| supraventricular tachycardia | 0/369 (0%) | 0 | 1/368 (0.3%) | 2 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| ventricular extrasystoles | 0/369 (0%) | 0 | 1/368 (0.3%) | 1 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| ventricular fibrillation | 0/369 (0%) | 0 | 1/368 (0.3%) | 1 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 1/371 (0.3%) | 1 |
| Coronary artery insufficiency | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 1/371 (0.3%) | 1 |
| Ear and labyrinth disorders | ||||||||||
| vertigo | 0/369 (0%) | 0 | 1/368 (0.3%) | 1 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||
| abdominal pain | 0/369 (0%) | 0 | 1/368 (0.3%) | 1 | 0/406 (0%) | 0 | 1/347 (0.3%) | 1 | 0/371 (0%) | 0 |
| constipation | 1/369 (0.3%) | 1 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| haemorrhoids | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 1/347 (0.3%) | 1 | 0/371 (0%) | 0 |
| reflux oesophagitis | 1/369 (0.3%) | 1 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| vomiting | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 1/406 (0.2%) | 1 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| gastritis | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 1/371 (0.3%) | 1 |
| erosive gastritis | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 1/371 (0.3%) | 1 |
| General disorders | ||||||||||
| chest pain | 3/369 (0.8%) | 3 | 4/368 (1.1%) | 5 | 1/406 (0.2%) | 1 | 0/347 (0%) | 0 | 1/371 (0.3%) | 1 |
| non cardiac chest pain | 1/369 (0.3%) | 1 | 1/368 (0.3%) | 1 | 3/406 (0.7%) | 3 | 2/347 (0.6%) | 2 | 1/371 (0.3%) | 1 |
| asthenia | 0/369 (0%) | 0 | 1/368 (0.3%) | 1 | 0/406 (0%) | 0 | 1/347 (0.3%) | 1 | 0/371 (0%) | 0 |
| Hepatobiliary disorders | ||||||||||
| acute cholecystitis | 2/369 (0.5%) | 2 | 1/368 (0.3%) | 1 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| bile duct stone | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 1/406 (0.2%) | 1 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| cholecystitis | 1/369 (0.3%) | 1 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| cholelithiasis | 1/369 (0.3%) | 1 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| hydrocholecystis | 1/369 (0.3%) | 1 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| Infections and infestations | ||||||||||
| bacterial arthritis | 1/369 (0.3%) | 1 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| bronchitis | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 1/406 (0.2%) | 1 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| infective cholecystitis | 1/369 (0.3%) | 1 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| diabetic gangrene | 0/369 (0%) | 0 | 1/368 (0.3%) | 2 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| diverticuliitis | 0/369 (0%) | 0 | 1/368 (0.3%) | 1 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| erysipelas | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 1/347 (0.3%) | 1 | 0/371 (0%) | 0 |
| lobar pneumonia | 1/369 (0.3%) | 1 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| pneumonia | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 2/406 (0.5%) | 2 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| urinary tract infection | 0/369 (0%) | 0 | 1/368 (0.3%) | 1 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| gastroenteritis | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 1/371 (0.3%) | 1 |
| respiratory tract infection | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 1/371 (0.3%) | 1 |
| Injury, poisoning and procedural complications | ||||||||||
| acetabulum fracture | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 1/406 (0.2%) | 1 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| hip fracture | 1/369 (0.3%) | 1 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| in stent coronary artery stenosis | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 1/347 (0.3%) | 1 | 1/371 (0.3%) | 1 |
| rib fracture | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 1/406 (0.2%) | 1 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| vascular pseudoaneurysm | 0/369 (0%) | 0 | 1/368 (0.3%) | 1 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| lead dislodgement | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 1/371 (0.3%) | 1 |
| road traffic accident | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 1/371 (0.3%) | 1 |
| Investigations | ||||||||||
| haemoglobin decrease | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 1/347 (0.3%) | 1 | 0/371 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||
| acidosis | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 1/347 (0.3%) | 1 | 0/371 (0%) | 0 |
| inadequate control of diabetes mellitus | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 2/406 (0.5%) | 2 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| hyperglycaemia | 0/369 (0%) | 0 | 1/368 (0.3%) | 1 | 0/406 (0%) | 0 | 1/347 (0.3%) | 1 | 1/371 (0.3%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||||
| back pain | 1/369 (0.3%) | 1 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| bone pain | 0/369 (0%) | 0 | 1/368 (0.3%) | 1 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 1/371 (0.3%) | 1 |
| musculoskeletal chest pain | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 1/347 (0.3%) | 1 | 0/371 (0%) | 0 |
| myalgia | 0/369 (0%) | 0 | 1/368 (0.3%) | 1 | 0/406 (0%) | 0 | 1/347 (0.3%) | 1 | 2/371 (0.5%) | 2 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| cholesteatoma | 0/369 (0%) | 0 | 1/368 (0.3%) | 1 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| chronic lymphocytic leukaemia | 0/369 (0%) | 0 | 1/368 (0.3%) | 1 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| pancreatic carcinoma | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 1/406 (0.2%) | 1 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| rectal cancer | 0/369 (0%) | 0 | 1/368 (0.3%) | 1 | 1/406 (0.2%) | 1 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| prostate cancer | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 1/371 (0.3%) | 1 |
| small intestine carcinoma | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 1/406 (0.2%) | 1 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| Nervous system disorders | ||||||||||
| dizziness | 1/369 (0.3%) | 1 | 0/368 (0%) | 0 | 1/406 (0.2%) | 1 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| epilepsy | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 1/406 (0.2%) | 1 | 1/347 (0.3%) | 1 | 0/371 (0%) | 0 |
| ischaemic stroke | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 1/347 (0.3%) | 1 | 0/371 (0%) | 0 |
| syncope | 1/369 (0.3%) | 1 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| cerebrovascular accident | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 1/371 (0.3%) | 1 |
| hemianopia | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 1/371 (0.3%) | 1 |
| paraparesis | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 1/371 (0.3%) | 1 |
| Psychiatric disorders | ||||||||||
| anxiety | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 1/406 (0.2%) | 1 | 0/347 (0%) | 0 | 1/371 (0.3%) | 1 |
| Renal and urinary disorders | ||||||||||
| acute prerenal failure | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 1/347 (0.3%) | 1 | 0/371 (0%) | 0 |
| renal failure | 0/369 (0%) | 0 | 1/368 (0.3%) | 1 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 1/371 (0.3%) | 1 |
| acute renal failure | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 2/406 (0.5%) | 2 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| urinary retention | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 1/347 (0.3%) | 1 | 0/371 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| dyspnoea | 0/369 (0%) | 0 | 2/368 (0.5%) | 2 | 1/406 (0.2%) | 1 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| pulmonary oedema | 1/369 (0.3%) | 1 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 2/347 (0.6%) | 2 | 0/371 (0%) | 0 |
| acute pulmonary oedema | 1/369 (0.3%) | 2 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 1/347 (0.3%) | 1 | 0/371 (0%) | 0 |
| respiratory distress | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 1/406 (0.2%) | 1 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| cough | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 1/371 (0.3%) | 1 |
| pulmonary embolism | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 1/371 (0.3%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||||||
| angioedema | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 1/347 (0.3%) | 1 | 0/371 (0%) | 0 |
| urticaria | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 1/347 (0.3%) | 1 | 0/371 (0%) | 0 |
| Vascular disorders | ||||||||||
| ischaemia | 1/369 (0.3%) | 1 | 1/368 (0.3%) | 1 | 1/406 (0.2%) | 1 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| angiopathy | 1/369 (0.3%) | 1 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| BP fluctuation | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 1/406 (0.2%) | 1 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| deep vein thrombosis | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 1/347 (0.3%) | 1 | 0/371 (0%) | 0 |
| extremity necrosis | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 1/406 (0.2%) | 1 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
| hypertension | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 0/406 (0%) | 0 | 1/347 (0.3%) | 1 | 0/371 (0%) | 0 |
| peripheral ischaemia | 0/369 (0%) | 0 | 0/368 (0%) | 0 | 1/406 (0.2%) | 1 | 0/347 (0%) | 0 | 0/371 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||
| 50mg Dabigatran Etexilate | 75mg Dabigatran Etexilate | 110mg Dabigatran Etexilate | 150mg Dabigatran Etexilate | Placebo | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/369 (0%) | 0/368 (0%) | 0/406 (0%) | 0/347 (0%) | 0/371 (0%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
| Name/Title | Boehringer Ingelheim Call Center |
|---|---|
| Organization | Boehringer Ingelheim Pharmaceuticals |
| Phone | 1-800-243-0127 |
| clintriage.rdg@boehringer-ingelheim.com |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00621855
Other Study ID Numbers:
- 1160.67
- RE-DEEM
- 2007-004301-99
First Posted:
Feb 22, 2008
Last Update Posted:
Mar 12, 2014
Last Verified:
Feb 1, 2014