SWEDES: Comparison Between Thrombolysis and Primary Percutaneous Coronary Intervention (PCI) to Treat ST-Segment Elevation Myocardial Infarction

• Sponsor: Sahlgrenska University Hospital, Sweden (Other)
• Overall Status: Completed
• CT.gov ID: NCT00806403
• Collaborator: Stockholm South General Hospital (Other), Region Örebro County (Other), Norra Alvsborgs Lans Hospital, Trollhattan (Other), Varberg Hospital, Sweden (Other)
• Enrollment: 205
• Locations: 5
• Arms: 2
• Duration (Months): 31
• Patients Per Site: 41
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

The main objective is to compare a fibrinolytic strategy with an interventional strategy initiated as early as possible, preferably in the pre-hospital phase, with respect to resolution of ST-segment elevation at 120 minutes after inclusion and Thrombolysis In Myocardial Infarction (TIMI) flow grade evaluated at a mandated coronary angiography 5 to 7 days after inclusion.

Condition or Disease	Intervention/Treatment	Phase
Acute Myocardial Infarction	Drug: reteplase 10+10 U; Procedure: primary PCI	Phase 4

Detailed Description

Patients in the fibrinolytic group received an intravenous injection of 30 mg enoxaparin followed by subcutaneous injections of 1 mg/kg body weight every 12 hours during hospital stay.

Patients in the invasive group were given an intravenous injection of enoxaparin of (0.75 mg/kg body weight) and abciximab as a intravenous bolus (0.25 mg/kg body weight) followed by a 12 hour infusion (10 microg/minute).

Secondary outcome measures were death, myocardial infarction and stroke alone or as a composite at 30 days.

Data on use of health care resources, loss of production and health-related quality of life were collected during one year. Cost-effectiveness was determined by comparing costs and quality-adjusted survival.

Study Design

• Study Type: Interventional
• Actual Enrollment: 205 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Very Early Initiation of Treatment With Thrombolysis and Low Molecular Weight Heparin, Versus Abciximab and Low Molecular Weight Heparin Followed by Percutaneous Coronary Intervention, for Acute ST-Elevation Myocardial Infarction
• Study Start Date: Nov 1, 2001
• Actual Primary Completion Date: Jun 1, 2003
• Actual Study Completion Date: Jun 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: thrombolysis	Drug: reteplase 10+10 U; comparison to primary PCI; Other Names: Rapilysin
Active Comparator: invasive	Procedure: primary PCI; comparison to thrombolysis; Other Names: primary percutaneous coronary intervention

Outcome Measures

Primary Outcome Measures

1. Number of Patients With ST-segment Elevation Resolution Equal or More Than 50% [120 minutes after inclusion]

   ST-segment elevation resolution was measured in the lead with most prominent ST elevation at time of inclusion

2. Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 [5-7 days after inclusion]

   Thrombolysis In Myocardial Infarction (TIMI) flow grade in the infarct related artery 5-7 days after inclusion.

Secondary Outcome Measures

1. Death [30 days]

2. Reinfarction [30 days]

3. Stroke [30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients presenting within 6 h after onset of chest pain lasting for more than 30 min and with significant ST-segment elevation on ECG.

Exclusion Criteria:

• BP >180/110

• Known bleeding disorder

• Cardiogenic shock

• CPR>10 min

• Ongoing anticoagulant therapy

• Renal insufficiency

• Weight >120 kg

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sahlgrenska University Hospital	Gothenburg		Sweden
2	Orebro University Hospital	Orebro		Sweden
3	Sodersjukhuset	Stockholm		Sweden
4	Norra Alvsborgs lans Hospital	Trollhattan		Sweden
5	Varberg Hospital	Varberg		Sweden

Sponsors and Collaborators

• Sahlgrenska University Hospital, Sweden
• Stockholm South General Hospital
• Region Örebro County
• Norra Alvsborgs Lans Hospital, Trollhattan
• Varberg Hospital, Sweden

Investigators

• Principal Investigator: Lars Grip, M.D. PhD, Sahlgren's University Hospital/S
• Study Chair: Leif Svensson, M.D. PhD, Stockholm South General Hospital
• Study Chair: Johan Herlitz, M.D. PhD, Sahlgren's University Hospital/S
• Study Chair: Mikael Dellborg, M.D. PhD, Sahlgren's University Hospital/O
• Study Chair: Ake Ohlsson, M.D. PhD, Stockholm South General Hospital
• Study Chair: Mikael Aasa, M.D., Stockholm South General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00806403
• Other Study ID Numbers: SWEDES 23/09/01
• First Posted: Dec 10, 2008
• Last Update Posted: Dec 10, 2008
• Last Verified: Nov 1, 2008

• Keywords provided by , ,: thrombolysis; primary PCI; abciximab; ST-segment resolution; TIMI flow
• Additional relevant MeSH terms: Myocardial Infarction; Infarction; Reteplase

Study Results

Participant Flow

Recruitment Details	From Nov. 2001 to May 2003. Cardiology Departments

Arm/Group Title	Thrombolysis	Invasive
Arm/Group Description	Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.	500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
Period Title: Overall Study
STARTED	104	101
COMPLETED	100	98
NOT COMPLETED	4	3

Baseline Characteristics

Arm/Group Title	Thrombolysis	Invasive	Total
Arm/Group Description	Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.	500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.	Total of all reporting groups
Overall Participants	104	101	205
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	55 52.9%	49 48.5%	104 50.7%
>=65 years	49 47.1%	52 51.5%	101 49.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.3 (12.4)	65.3 (10.9)	64.8 (11.7)
Sex: Female, Male (Count of Participants)
Female	26 25%	27 26.7%	53 25.9%
Male	78 75%	74 73.3%	152 74.1%
Region of Enrollment (participants) [Number]
Sweden	104 100%	101 100%	205 100%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With ST-segment Elevation Resolution Equal or More Than 50%
Description	ST-segment elevation resolution was measured in the lead with most prominent ST elevation at time of inclusion
Time Frame	120 minutes after inclusion

Outcome Measure Data

Analysis Population Description

Analysis was made on intention to treat(ITT) basis.Patients with electrocardiograms (ECGs) suitable for analysis at inclusion and at 120 minutes therafter were included in the analysis.

Arm/Group Title	Thrombolysis	Invasive
Arm/Group Description	Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.	500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
Measure Participants	75	74
Number [participants]	47 45.2%	51 50.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Thrombolysis, Invasive
	Comments	Null hypothesis:there is no difference in ST resolution at 120 minutes after inclusion between thrombolysis and primary PCI. The power calculation was based on the aim to prove a 50% reduction of failure to achive at least a 50% ST resolution (40% failure in thrombolysis group and 20% failure in Primary PCI group). With a power of 80% and a significance level of 0.05 (2-sided test), a total of 166 patients would be required.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.56
	Comments
	Method	Fisher Exact
	Comments

2. Secondary Outcome

Title	Death
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Analysis was made on intention to treat (ITT) basis.

Arm/Group Title	Thrombolysis	Invasive
Arm/Group Description	Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.	500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
Measure Participants	104	101
Number [participants]	4 3.8%	3 3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Thrombolysis, Invasive
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	1.00
	Comments
	Method	Fisher Exact
	Comments

3. Primary Outcome

Title	Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3
Description	Thrombolysis In Myocardial Infarction (TIMI) flow grade in the infarct related artery 5-7 days after inclusion.
Time Frame	5-7 days after inclusion

Outcome Measure Data

Analysis Population Description

Patient were analyzed on intention to treat (ITT) basis. The per protocol angiography on day 5-7 after inclusion was used for analysis of Thrombolysis In Myocardial Infarction (TIMI) flow grade in the infarct related coronary artery.

Arm/Group Title	Thrombolysis	Invasive
Arm/Group Description	Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.	500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
Measure Participants	65	79
Number [participants]	35 33.7%	56 55.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Thrombolysis, Invasive
	Comments	Null hypothesis:there is no difference in number of patients with TIMI 3 flow at 5-7 days after inclusion between thrombolysis and primary PCI. The power calculation was based on the aim to prove a 65% reduction of failure to achive TIMI 3 flow (30% failure in thrombolysis group and 10% failure in Primary PCI group). With a power of 90% and a significance level of 0.05 (2-sided test), a total of 180 patients would be required.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	Fisher Exact
	Comments

4. Secondary Outcome

Title	Reinfarction
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Analysis made on intention to treat (ITT) basis.

Arm/Group Title	Thrombolysis	Invasive
Arm/Group Description	Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.	500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
Measure Participants	104	101
Number [Participants]	2 1.9%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Thrombolysis, Invasive
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.50
	Comments
	Method	Fisher Exact
	Comments

5. Secondary Outcome

Title	Stroke
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Analysis made on intention to treat (ITT) basis.

Arm/Group Title	Thrombolysis	Invasive
Arm/Group Description	Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.	500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
Measure Participants	104	101
Number [Participants]	3 2.9%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Thrombolysis, Invasive
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.21
	Comments
	Method	Fisher Exact
	Comments

Adverse Events

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.