Trial Outcomes & Findings for Comparison Between Thrombolysis and Primary Percutaneous Coronary Intervention (PCI) to Treat ST-Segment Elevation Myocardial Infarction (NCT NCT00806403)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

205 participants

Primary outcome timeframe

120 minutes after inclusion

Results posted on

2008-12-10

Participant Flow

From Nov. 2001 to May 2003. Cardiology Departments

Participant milestones

Participant milestones
Measure	Thrombolysis 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.	Invasive 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.
Overall Study STARTED	104	101
Overall Study COMPLETED	100	98
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Thrombolysis 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.	Invasive 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.
Overall Study Death	4	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Thrombolysis n=104 Participants 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.	Invasive n=101 Participants 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 n=205 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	55 Participants n=5 Participants	49 Participants n=7 Participants	104 Participants n=5 Participants
Age, Categorical >=65 years	49 Participants n=5 Participants	52 Participants n=7 Participants	101 Participants n=5 Participants
Age Continuous	64.3 years STANDARD_DEVIATION 12.4 • n=5 Participants	65.3 years STANDARD_DEVIATION 10.9 • n=7 Participants	64.8 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	27 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	78 Participants n=5 Participants	74 Participants n=7 Participants	152 Participants n=5 Participants
Region of Enrollment Sweden	104 participants n=5 Participants	101 participants n=7 Participants	205 participants n=5 Participants

PRIMARY outcome

Timeframe: 120 minutes after inclusion

Population: 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.

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

Outcome measures

Outcome measures
Measure	Thrombolysis n=75 Participants 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.	Invasive n=74 Participants 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.
Number of Patients With ST-segment Elevation Resolution Equal or More Than 50%	47 participants	51 participants

PRIMARY outcome

Timeframe: 5-7 days after inclusion

Population: 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.

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

Outcome measures

Outcome measures
Measure	Thrombolysis n=65 Participants 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.	Invasive n=79 Participants 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.
Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3	35 participants	56 participants

SECONDARY outcome

Timeframe: 30 days

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

Outcome measures

Outcome measures
Measure	Thrombolysis n=104 Participants 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.	Invasive n=101 Participants 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.
Death	4 participants	3 participants

SECONDARY outcome

Timeframe: 30 days

Population: Analysis made on intention to treat (ITT) basis.

Outcome measures

Outcome measures
Measure	Thrombolysis n=104 Participants 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.	Invasive n=101 Participants 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.
Reinfarction	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Population: Analysis made on intention to treat (ITT) basis.

Outcome measures

Outcome measures
Measure	Thrombolysis n=104 Participants 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.	Invasive n=101 Participants 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.
Stroke	3 Participants	0 Participants

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lars Grip

Sahlgren's University Hospital/S, Gothenburg

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place