Clincosm LogoSign in Get a demo

PACIFIC-AMI: Study to Gather Information About the Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following an Acute Heart Attack

Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT04304534
Collaborator
(none)
1,592
Enrollment
160
Locations
4
Arms
20.2
Actual Duration (Months)
10
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works on top of a dual antiplatelet therapy (acetylsalicylic acid +/- clopidogrel) in patients following a recent heart attack (myocardial infarction) that happens when a blood vessel in the heart suddenly becomes blocked. BAY 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral FXIa inhibitor.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
1592 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Multicenter, Randomized, Placebo Controlled, Double-blind, Parallel Group, Dose-finding Phase 2 Study to Evaluate the Efficacy and Safety of BAY 2433334 in Patients Following an Acute Myocardial Infarction
Actual Study Start Date :
Jun 17, 2020
Actual Primary Completion Date :
Feb 21, 2022
Actual Study Completion Date :
Feb 21, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: BAY 2433334 high dose

Drug: BAY2433334
Tablet, taken orally once a day.
Experimental: BAY 2433334 medium dose

Drug: BAY2433334
Tablet, taken orally once a day.
Experimental: BAY 2433334 low dose

Drug: BAY2433334
Tablet, taken orally once a day.
Placebo Comparator: BAY2433334 matching placebo

Other: BAY2433334 matching placebo
Tablet, taken orally once a day.

Outcome Measures

Primary Outcome Measures

  1. Time from randomization to first occurrence of any of the components of the composite outcome including Cardiovascular (CV) death, Myocardial infarction (MI), stroke and stent thrombosis [From baseline up to 12 months]

  2. Time from randomization to first occurrence of Bleeding Academic Research Consortium (BARC) bleeding definition type 2, 3 and 5 [From baseline up to 12 months]

Secondary Outcome Measures

  1. Time from randomization to death (all cause mortality) [From baseline up to 12 months]

  2. Time from randomization to CV death [From baseline up to 12 months]

  3. Time from randomization to first occurrence of MI [From baseline up to 12 months]

  4. Time from randomization to first occurrence of stroke (ischemic and hemorrhagic) [From baseline up to 12 months]

  5. Time from randomization to first occurrence of stent thrombosis [From baseline up to 12 months]

  6. Time from randomization to first occurrence of all bleeding [From baseline up to 12 months]

  7. Time from randomization to first occurrence of BARC bleeding definition Type 3, 5 [From baseline up to 12 months]

  8. Time from randomization to first occurrence of BARC bleeding definition Type 1, 2, 3, 5 [From baseline up to 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Participants must be 45 years of age or older, at the time of signing the informed consent

  • Acute myocardial infarction (excluding MI associated with PCI or CABG revascularization procedures) with:

  • clinical symptoms of acute myocardial infarction AND

  • elevated biomarkers of myocardial necrosis (creatine kinase-muscle and brain isoenzyme [CK-MB] or cardiac troponins) AND

  • at least one of the following risk factors need to be fulfilled:

  • Age ≥ 65 years

  • Prior MI (before the index AMI event)

  • Prior peripheral arterial disease

  • Diabetes Mellitus

  • Prior coronary artery bypass grafting (CABG) AND

  • initial angiography and revascularization procedures, either PCI or CABG, as treatment for the index event performed before randomization. (Note: a planned, staged PCI procedure can be performed after randomization)

  • Plan for dual antiplatelet therapy (ASA + P2Y12 inhibitor) after hospital discharge for the index AMI

  • Randomization during hospitalization for the index AMI event and latest within 5 days of hospital admission

  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent has to be signed before any study-specific procedure.

Exclusion Criteria:

  • Hemodynamically significant ventricular arrhythmias or cardiogenic shock at time of randomization

  • Active bleeding; known bleeding disorder, history of major bleeding (intracranial, retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding within last 6 months of randomization

  • Planned use or requirement of full dose and long term anticoagulation therapy during study conduct.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Valley Clinical Trials, Inc. Covina California United States 91723
2 Florida Premier Cardiology Boynton Beach Florida United States 33437
3 Clearwater Cardiovascular & Interventional Cons - Clearwater Clearwater Florida United States 33756
4 Cardiology Associates Research Company Daytona Beach Florida United States 32117
5 Southwest Florida Research Naples Florida United States 34102
6 Cardiology Partners Clinical Research Institute Palm Beach Gardens Florida United States 33410
7 Columbus Regional Research Institute Columbus Georgia United States 31904
8 Reid Health Richmond Indiana United States 47374
9 Midwest Heart & Vascular Specialists Overland Park Kansas United States 66211
10 Cardiovascular Associates Research, LLC Covington Louisiana United States 70433
11 Southern Clinical Research, LLC Zachary Louisiana United States 70791
12 Maryland Cardiovascular Specialists Baltimore Maryland United States 21229
13 White Oak Medical Center Silver Spring Maryland United States 20904
14 St. Mary's/Duluth Clinic Health System Duluth Minnesota United States 55805
15 Logan Health Research Kalispell Montana United States 59901
16 Methodist Physicians Clinic Omaha Nebraska United States 68114
17 The Valley Hospital, Inc. Ridgewood New Jersey United States 07450
18 Trinity Medical WNY Cheektowaga New York United States 14227
19 Jefferson Heart Institute Philadelphia Pennsylvania United States 19107
20 Cardiovascular Research of Knoxville Powell Tennessee United States 37849
21 PharmaTex Research, LLC Amarillo Texas United States 79109
22 North Texas Research Associates McKinney Texas United States 75071
23 Klinikum Klagenfurt am Wörthersee Klagenfurt Kärnten Austria 9020
24 Universitätsklinikum St. Pölten St. Pölten Niederösterreich Austria 3100
25 Landesklinikum Wiener Neustadt Wiener Neustadt Niederösterreich Austria 2700
26 Krankenhaus St. Josef Braunau Braunau Oberösterreich Austria 5280
27 Kepler Universitätsklinikum Campus III Linz Oberösterreich Austria 4021
28 Medizinische Universität Graz Graz Steiermark Austria 8036
29 Universitätsklinikum AKH Wien Wien Austria 1090
30 Klinik Ottakring - Wilhelminenspital Wien Austria 1160
31 Klinik Floridsdorf - Krankenhaus Nord Wien Austria 1210
32 OL Vrouwziekenhuis - Campus Aalst Aalst Belgium 9300
33 Imeldaziekenhuis - St-Elisabethkliniek Bonheiden Belgium 2820
34 AZ St-Jan Brugge Oostende AV Brugge Belgium 8000
35 CU Saint-Luc/UZ St-Luc Bruxelles - Brussel Belgium 1200
36 Ziekenhuis Oost-Limburg Genk Belgium 3600
37 Jessa Ziekenhuis Hasselt Belgium 3500
38 UZ Leuven Gasthuisberg Leuven Belgium 3000
39 CHR de la Citadelle Liege Belgium 4000
40 Fakultni nemocnice Brno Brno Czechia 625 00
41 Fakultni nemocnice u sv. Anny Brno Czechia 656 91
42 Nemocnice Ceske Budejovice, a.s. Ceske Budejovice Czechia 370 01
43 Fakultni Nemocnice Hradec Kralove Hradec Kralove Czechia 500 05
44 Fakultni nemocnice Plzen Plzen Czechia 304 60
45 Fakultni nemocnice Kralovske Vinohrady Praha 10 Czechia 10034
46 Vseobecna fakultni nemocnice v Praze Praha 2 Czechia 12808
47 Institut Klinicke a Experimentalni Mediciny Praha 4 Czechia 140 21
48 Fakultni nemocnice v Motole Praha 5 Czechia 150 06
49 Ustredni vojenska nemocnice Praha Praha 6 Czechia 169 02
50 Nemocnice Slany Slany Czechia 274 01
51 Universitätsherzzentrum Freiburg - Bad Krozingen Bad Krozingen Baden-Württemberg Germany 79189
52 Universitätsklinikum Essen Essen Nordrhein-Westfalen Germany 45147
53 St. Vinzenz-Hospital Köln Nordrhein-Westfalen Germany 50733
54 Kliniken Maria Hilf GmbH Mönchengladbach Nordrhein-Westfalen Germany 41063
55 Sana-Klinikum Remscheid GmbH Remscheid Nordrhein-Westfalen Germany 42859
56 Forschungszentrum Ruhr - KliFoCenter GmbH Witten Nordrhein-Westfalen Germany 58455
57 Universitätsmedizin der Johannes Gutenberg Universität Mainz Mainz Rheinland-Pfalz Germany 55131
58 Krankenhaus Dresden-Friedrichstadt Dresden Sachsen Germany 01067
59 Universitätsklinikum Hamburg Eppendorf (UKE) Hamburg Germany 20246
60 Universitätsklinikum Heidelberg Heidelberg Germany 69120
61 Allami Szivkorhaz Balatonfured Hungary 8230
62 Budai Irgalmasrendi Korhaz Budapest Hungary 1023
63 University of Semmelweis/ Semmelweis Egyetem Budapest Hungary 1122
64 Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz Budapest Hungary
65 Debreceni Egyetem Klinikai Kozpont Debrecen Hungary 4032
66 Petz Aladar Megyei Oktato Korhaz Gyor Hungary 9023
67 Pandy Kalman Korhaz Gyula Hungary 5700
68 Somogy Megyei Kaposi Mor Oktato Korhaz Kaposvar Hungary 7400
69 Josa Andras Hospital Nyiregyhaza Hungary H-4400
70 Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz Szolnok Hungary 5000
71 Zala Megyei Szent Rafael Korhaz Zalaegerszeg Hungary 8900
72 A.O. San Pio Benevento Campania Italy 82100
73 ASL Caserta Caserta Campania Italy 81031
74 A.O.U. di Ferrara Ferrara Emilia-Romagna Italy 44124
75 Asl Roma 2 Roma Lazio Italy 00157
76 IRCCS Ospedale Policlinico San Martino Genova Liguria Italy 16132
77 Istituto Clinico Humanitas - Humanitas Mirasole S.p.A. Milano Lombardia Italy 20089
78 IRCCS Centro Cardiologico Monzino Milano Lombardia Italy 20138
79 ASST Valle Olona Varese Lombardia Italy 21047
80 A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi" Ancona Marche Italy 60126
81 A.O. S.Croce e Carle Cuneo Piemonte Italy 12100
82 ASL TO3 di Collegno e Pinerolo Torino Piemonte Italy 10098
83 A.O.U. di Sassari Sassari Sardegna Italy
84 AUSL Toscana Sud-Est Grosseto Toscana Italy 58100
85 ULSS3 Serenissima Venezia Veneto Italy 30035
86 Daido Hospital, Social Medical Corporation Kojunkai Nagoya Aichi Japan 457-8511
87 Chiba-Nishi General Hospital Matsudo Chiba Japan 270-2251
88 Fukuoka Tokushukai Hospital Kasuga Fukuoka Japan 816-0864
89 Kokura Memorial Hospital Kitakyushu Fukuoka Japan 802-8555
90 Ogaki Municipal Hospital Ogaki Gifu Japan 503-8502
91 Hokkaido Cardiovascular Hospital Sapporo Hokkaido Japan 064-8622
92 Hyogo Brain and Heart Center Himeji Hyogo Japan 670-0981
93 Takahashi Hospital Kobe Hyogo Japan 654-0026
94 Nishinomiya Watanabe Cardiovascular Center Nishinomiya Hyogo Japan 662-0911
95 Tsukuba Medical Center Hospital Tsukuba Ibaraki Japan 305-8558
96 Kanagawa Cardiovascular and Respiratory Center Yokohama Kanagawa Japan 236-0051
97 Kishiwada Tokushukai Hospital Kishiwada Osaka Japan 596-0042
98 Shin-Kuki General Hospital Kuki Saitama Japan 346-8530
99 Saitama Sekishinkai Hospital Sayama Saitama Japan 350-1305
100 Tokyo Medical and Dental University Hospital Bunkyo-ku Tokyo Japan 113-8519
101 Fukui Prefectural Hospital Fukui Japan 910-8526
102 Japanese Red Cross Fukuoka Hospital Fukuoka Japan 815-8555
103 Saiseikai Kumamoto Hospital Kumamoto Japan 861-4193
104 Oita Prefectural Hospital Oita Japan 870-8511
105 Osaka General Medical Center Osaka Japan 558-8558
106 Noord West Ziekenhuisgroep-Medisch Centrum Alkmaar Alkmaar Netherlands 1815 JD
107 Reinier de Graaf Gasthuis Delft Netherlands 2625 AD
108 Jeroen Bosch Ziekenhuis Den Bosch Netherlands 5223 GZ
109 Albert Schweitzer Ziekenhuis, Locatie Dordwijk Dordrecht Netherlands 3318 AT
110 Zuyderland Medisch Centrum Heerlen Netherlands 6401 CX
111 Elkerliek Ziekenhuis, Lokatie Helmond Helmond Netherlands 5707 HA
112 Leids Universitair Medisch Centrum Leiden Netherlands 2333 ZA
113 Universitair Medisch Centrum St. Radboud Nijmegen Netherlands 6525 GA
114 Canisius Wilhelmina Ziekenhuis Nijmegen Netherlands 6532 SZ
115 Bravis Ziekenhuis Roosendaal Netherlands 4708 AE
116 Ikazia Ziekenhuis Rotterdam Netherlands 3083 AN
117 VieCuri - Medisch Centrum voor Noord-Limburg locatie Venlo Venlo Netherlands 5912 BL
118 Gelre Ziekenhuizen Zutphen Zutphen Netherlands 7207 AE
119 Isala Zwolle Netherlands 8025 AB
120 Uniwersytecki Szpital Kliniczny w Bialymstoku Bialystok Poland 15-276
121 Szpital sw. Wincentego a Paulo Gdynia Poland 81-348
122 Samodzielny Publiczny Specjalistyczny Szpital Zachodni Grodzisk Mazowiecki Poland 05-825
123 Uniwersytecki Szpital Kliniczny w Opolu Opole Poland 45-401
124 Szpital Wojewodzki Nr 2 Rzeszow Poland 35-301
125 Uniwersyteckie Centrum Kliniczne Warszawskiego UM Warszawa Poland 02-097
126 Szpital Grochowski im. dr.med. Rafala Masztaka Warszawa Poland 04-073
127 Uniwersytecki Szpital Kliniczny UM we Wroclawiu Wroclaw Poland 50-556
128 Ciutat Sanitària i Universitària de Bellvitge L'Hospitalet de Llobregat Barcelona Spain 08907
129 Hospital Universitario "Virgen de la Arrixaca" El Palmar (Murcia) Murcia Spain 30120
130 Hospital Álvaro Cunqueiro Babio - Beade Pontevedra Spain 36312
131 Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona Spain 08035
132 Hospital de la Santa Creu i de Sant Pau Barcelona Spain 08041
133 Hospital Universitario Virgen de las Nieves Granada Spain 18014
134 Hospital Ramón y Cajal Madrid Spain 28034
135 Hospital Clínico Universitario San Carlos Madrid Spain 28040
136 Hospital Universitario 12 de Octubre Madrid Spain 28041
137 Hospital Universitario Virgen de la Macarena Sevilla Spain 41071
138 Hospital Joan XXIII Tarragona Spain 43005
139 Hospital Universitari i Politècnic La Fe Valencia Spain 46026
140 Falu Lasarett Falun Sweden 791 82
141 Sahlgrenska Universitetssjukhuset Göteborg Sweden 413 45
142 Länssjukhuset Ryhov Jönköping Sweden 551 85
143 Skånes Universitetssjukhus Lund Sweden 222 42
144 Danderyds sjukhus Stockholm Sweden 182 88
145 Länssjukhuset Sundsvall-Härnösand Sundsvall Sweden 851 86
146 Akademiska Sjukhuset Uppsala Sweden 751 85
147 Västmanlands Sjukhus Västerås Västerås Sweden 721 89
148 Universitetssjukhuset Örebro Örebro Sweden 701 85
149 Kantonsspital Aarau Aarau Aargau Switzerland 5001
150 Kantonsspital Baselland - Standort Liestal Liestal Basel-Landschaft Switzerland 4410
151 Centre Hospitalier Universitaire Vaudois (CHUV) Lausanne Vaud Switzerland 1011
152 Kantonsspital Baden Baden Switzerland 5404
153 Hôpital Cantonal Universitaire de Genève Genève Switzerland 1205
154 Ospedale regionale di Lugano Lugano Switzerland 6900
155 Luzerner Kantonsspital Luzern Switzerland 6000
156 Lister Hospital Stevenage Hertfordshire United Kingdom SG1 4AB
157 Freeman Hospital Newcastle Upon Tyne Tyne And Wear United Kingdom NE7 7DN
158 Worcestershire Acute Hospital Trust Worcester Worcestershire United Kingdom WR5 1DD
159 Imperial College London London United Kingdom W12 0HS
160 Wythenshawe Hospital Manchester United Kingdom M23 9LT

Sponsors and Collaborators

  • Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT04304534
Other Study ID Numbers:
  • 20603
  • 2019-003244-79
First Posted:
Mar 11, 2020
Last Update Posted:
Mar 11, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Myocardial Infarction
Infarction

Study Results

No Results Posted as of Mar 11, 2022