Phase 4 N=205 Randomized Treatment

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

Acute Myocardial Infarction

Bottom Line

View on ClinicalTrials.gov: NCT00806403 ↗

Enrolled (actual)

205

Serious AEs

—

Results posted

Dec 2008

Primary outcome: Primary: Number of Patients With ST-segment Elevation Resolution Equal or More Than 50% — 47; 51 participants — p=0.56

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: reteplase 10+10 U (Drug); primary PCI (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Sahlgrenska University Hospital
Primary completion: Jun 2003

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With ST-segment Elevation Resolution Equal or More Than 50%	47; 51	0.56
PRIMARY Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3	35; 56	0.04 sig
SECONDARY Death	4; 3	1.00
SECONDARY Reinfarction	2; 0	0.50
SECONDARY Stroke	3; 0	0.21

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00806403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.