Phase 4
N=609
STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction
Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT02777580 ↗Enrolled (actual)
609
Serious AEs
16.7%
Results posted
Oct 2024
Primary outcome: Primary: Successful Reperfusion — 305; 149 Participants — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tenecteplase (Drug); Clopidogrel (Drug); Coronary angiography (Procedure); Primary PCI (Procedure)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- KU Leuven
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Successful Reperfusion |
305; 149 | 0.05 |
| PRIMARY Composite Clinical Efficacy End Point: All Cause Death, Shock, CHF and Reinfarction at 30 Days |
51; 27 | — |
| PRIMARY Total Stroke |
9; 1 | — |
| PRIMARY Major Non-intrancranial Bleedings |
5; 2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age equal or greater than 60 years
- Onset of symptoms 2 minutes) within the past 2 weeks
- Known acute pericarditis and/or subacute bacterial endocarditis
- Known acute pancreatitis or known severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis
- Dementia
- Known severe renal insufficiency
- Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 7 days
- Known allergic reactions to tenecteplase, clopidogrel, enoxaparin and aspirin
- Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk if the investigational therapy is initiated.
Data sourced from ClinicalTrials.gov (NCT02777580). 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.