STREAM-2 (STrategic Reperfusion in elderly patients Early After Myocardial Infarction)

Phase 1

Conditions: MedDRA version: 20.0Level: LLTClassification code 10064345Term: ST segment elevation myocardial infarctionSystem Organ Class: 100000011652
ST-elevation myocardial infarction within 3 hours of onset of symptoms
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2016-001642-26-ES

Lead Sponsor: euven Research & Development (LRD) at University of Leuven, Belgium

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 600

Inclusion Criteria

1.Age equal or greater than 70 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 600

Exclusion Criteria

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.Known severe renal insufficiency
14.Prolonged cardiopulmonary resuscitation (> 2 minutes) within the past 2 weeks
15.Known acute pericarditis and/or subacute bacterial endocarditis
16.Known acute pancreatitis or known severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis
17.Dementia
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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: not applicable;Primary end point(s): Number of patients achieving = 50 % ST-segment resolution before and after PCI in lead with maximal ST elevation at baseline; % rescue PCI; TIMI flow grades;Timepoint(s) of evaluation of this end point: 30 days post randomisation;Main Objective: In elderly patients = 70yrs 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.

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 30 days post randomisation;Secondary end point(s): Clinical events of interest i.e. death, shock, heart failure, recurrent MI and aborted MI will be recorded and assessed as single or composite endpoints for evaluation as noted in the statistical analytical plan. <br>Total stroke, intracranial haemorrhage, ischaemic stroke, haemorrhagic conversion.<br>Non-intracranial bleeds (total, major, minor, and blood transfusions).<br>Serious cardiac events (e.g. death , congestive heart failure, reinfarction, resuscitated ventricular fibrillation, repeat target vessel recanalization, stent thrombosis, total AV block etc).