CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 609 enrolled
Drug / intervention
Tenecteplase +3 moredrug
Likely dose
Half-dose tenecteplase plus clopidogrel 300 mg loading dose, then 75 mg once daily for 1 yearAI-extracted
Key inclusion· 3
  • Age ≥60 years
  • Symptom onset <3 hours before randomization
  • 12-lead ECG diagnostic of acute STEMI: ≥2 mm ST-elevation across ≥2 contiguous precordial leads (V1-V6) or leads I and aVL with minimum combined total ≥4 mm ST-elevation; OR ≥2 mm ST-elevation in ≥2 contiguous inferior leads (II, III, aVF) with minimum combined total ≥4 mm ST-elevation
Key exclusion· 18
  • Expected PCI cannot be performed within 60 minutes of diagnosis or inability to arrive at catheterization laboratory within 3 hours
  • Prior CABG
  • Left bundle branch block or ventricular pacing
  • Cardiogenic shock (Killip Class 4)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02777580
NCT02777580Phase 4Completed

STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction

KU Leuven·interventional·Posted May 19, 2016·Updated Oct 4, 2024

In Brief

A Phase 4 clinical trial evaluating Tenecteplase, Clopidogrel, and 2 other interventions for Myocardial Infarction. Completed, enrolled 609 participants across 50 sites in 10 countries.

Detailed Summary

In patients ≥ 60yrs with acute ST-elevation myocardial infarction randomised within 3 hours of onset of symptoms the efficacy and safety of a strategy of early fibrinolytic treatment with half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by catheterisation within 6-24 hours or rescue coronary intervention as required, will be compared to a strategy of primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Brazil, Canada, Chile, France, Mexico, Montenegro, Russia, Serbia, Spain

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 19, 2016
Enrollment StartAug 1, 2017
Primary CompletionOct 13, 2022
Study CompletionSep 30, 2023
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 10.1 years ago

Interventions

Tenecteplasedrug

Half dose Tenecteplase

Clopidogreldrug

300 mg p.o. initial loading dose. Maintenance dose of 75 mg p.o. once daily. The maintenance dose of Clopidogrel (75 mg p.o. per day) should be continued for 1 year.

Coronary angiographyprocedure

Coronary angiography followed by PCI or CABG if required, rescue PCI if required

Primary PCIprocedure

Primary PCI accoring to local standards