STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction (STREAM-2)

Catholic University (KU) of Leuven

Status and phase: Completed; Phase 4

Conditions: Myocardial Infarction

Treatments: Drug: Clopidogrel; Drug: Tenecteplase; Procedure: Coronary angiography; Procedure: Primary PCI

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02777580

LRD.2016.STREAM2

Details and patient eligibility

About

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.

Enrollment: 609 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age equal or greater than 60 years

2. Onset of symptoms < 3 hours prior to randomisation

3. 12-lead ECG indicative of an acute STEMI (ST-elevation will be measured from the J point; scale: 1 mm per 0.1 mV):

   • ≥ 2 mm ST-elevation across 2 contiguous precordial leads (V1-V6) or leads I and aVL for a minimum combined total of ≥ 4 mm ST-elevation or
   • ≥ 2 mm ST-elevation in 2 contiguous inferior leads (II, III, aVF) for a minimum combined total of ≥ 4 mm ST-elevation

4. Informed consent received

Exclusion criteria

1. 1. Expected performance of PCI < 60 minutes from diagnosis (qualifying ECG) or inability to arrive at the catheterisation laboratory within 3 hours
2. Previous CABG
3. Left bundle branch block or ventricular pacing
4. Patients with cardiogenic shock - Killip Class 4
5. Patients with a body weight < 55 kg (known or estimated)
6. Uncontrolled hypertension, defined as sustained blood pressure ≥ 180/110 mm Hg (systolic BP ≥ 180 mm Hg and/or diastolic BP ≥ 110 mm Hg) prior to randomisation
7. Known prior stroke or TIA
8. Recent administration of any i.v. or s.c. anticoagulation within 12 hours, including unfractionated heparin, enoxaparin, and/or bivalirudin or current use of oral anticoagulation (i.e. warfarin or a NOACs)
9. Active bleeding or known bleeding disorder/diathesis
10. Known history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) or recent trauma to the head or cranium (i.e. < 3 months)
11. Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with the current myocardial infarction)
12. Clinical diagnosis associated with increased risk of bleeding including known active peptic ulceration and/or neoplasm with increased bleeding risk
13. Prolonged cardiopulmonary resuscitation (> 2 minutes) within the past 2 weeks
14. Known acute pericarditis and/or subacute bacterial endocarditis
15. Known acute pancreatitis or known severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis
16. Dementia
17. Known severe renal insufficiency
18. Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 7 days
19. Known allergic reactions to tenecteplase, clopidogrel, enoxaparin and aspirin
20. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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609 participants in 2 patient groups

Pharmaco-invasive strategy

Experimental group

Description:

Half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by coronary angiography within 6-24 hours or rescue coronary intervention as required.

Treatment:

Procedure: Coronary angiography

Drug: Clopidogrel

Drug: Tenecteplase

Standard primary PCI

Active Comparator group

Description:

Primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards.

Treatment:

Procedure: Primary PCI