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

Primary Purpose

Myocardial Infarction

Status

Active

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Tenecteplase

Clopidogrel

Coronary angiography

Primary PCI

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Thrombolytic Therapy, Primary PCI

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age equal or greater than 60 years
Onset of symptoms < 3 hours prior to randomisation
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
Informed consent received

Exclusion Criteria:

1. Expected performance of PCI < 60 minutes from diagnosis (qualifying ECG) or inability to arrive at the catheterisation laboratory within 3 hours
Previous CABG
Left bundle branch block or ventricular pacing
Patients with cardiogenic shock - Killip Class 4
Patients with a body weight < 55 kg (known or estimated)
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
Known prior stroke or TIA
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)
Active bleeding or known bleeding disorder/diathesis
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)
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)
Clinical diagnosis associated with increased risk of bleeding including known active peptic ulceration and/or neoplasm with increased bleeding risk
Prolonged cardiopulmonary resuscitation (> 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.

Sites / Locations

Liverpool Hospital - Cardiology Department
Centro de Pesquisa São Lucas - Hospital E Maternidade Celso Pierro
University of Alberta Hospital
Hospital Regional de Antofagasta
Hospital Comunitario de Mejillones
Hospital de Melipilla
Hospital Regional de Rancagua
SAR Rancagua
Hospital San Juan de Dios
Hospital de Talagante
Hospital de Tocopilla
CH Louis Pradel - Hospices civils de Lyon
CH Cahors - SAMU 46
CH de Chateauroux
CH Sud Francilien - Service Cardiologie
Centre Hospitalier de Versailles
CHRU de Lille
CH St. Joseph - St Luc - Lyon
Groupe Hospitalier Sud Ile de France - CH de Melun - Service SAMU 77
Clinque du Pont de Chaume
CHU de Rennes
CH Lucien Hussel
Hospital Gea Gonzalez
Instituto Nacional de Cardiologia Ignacio Chavez
JZU Blazo Orlandic
General Hospital Danilo the First Cetinje
General Hospital of Niksic
Clinical Centar of Montenegro
Federal State Budgetary Inst "Research Inst. for Complex Issues of Card. Diseases"
State Budgetary Healthcare Inst. Kemerovo-Clinical Emergency Care Station
Federal State Budgetary Scientific Inst "Tomsk Nat Research Med.Center of Russian Academy Sciences"
Tomsk Regional State Autonomous Healthcare Institution Emergency Care Station
State Budgetary Healthcare Institution of Tverskoy Region "Region Clinical Hospital"
Tver Region State Budgetary Healthcare Institution "Tver Emergency Station"
Clinical Center of Serbia, Cardiology Clinic
Military Medical Academy, Clinic for Emergency Internal Medicine
Institute for cardiovascular diseases Dedinje, Cardiovascular research sector
General Hospital Cuprija, Cardiology Department
General Hospital Jagodina/Intenal Medicine department
Clinical Center Kragujevac, Cardiology Clinic
General Hospital Pancevo/Department of internal medicine - cardiology section
General Hospital "Sveti Luka" Smederevo, Dept of Internal Med - Cardiology Section
Institute for cardiovascular diseases Vojvodina - Sremska Kamenica, Cardiology Clinic
Opsta bolnica Vrbas, Cardiology Department
General Hospital Vrsac/Cardiology department with coronary unit
General Hospital "Dr. Laza K. Lazarevic" Sabac, Internal medicine department
Hospital Virgen de la Victoria, Unidad de Cuidados Intensivos
Hospital de Antequera, Unidad de Cuidados Intensivos
Hospital Serrania Ronda, Unidad de Cuidados Intensivos
Hospital Comarcal Axarquia, Unidad de Cuidados Intensivos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pharmaco-invasive strategy

Standard primary PCI

Arm 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.

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

Outcomes

Primary Outcome Measures

Number of patients achieving ≥ 50 % ST-segment resolution before and after PCI; needing rescue PCI; demonstrating TIMI flow grades (0,1,2,3); with aborted MI.

Number of patients with stroke (total, intracranial haemorrhage, ischaemic, haemorrhagic conversion) and non-intracranial bleeds. Number of patients with serious cardiac events.

Serious cardiac events (e.g. death , congestive heart failure, reinfarction, resuscitated ventricular fibrillation, repeat target vessel recanalization, stent thrombosis, total AV block etc).

Composite endpoints (e.g. death, shock, heart failure and recurrent MI) will be assessed as described in the statistical analytical plan.

Secondary Outcome Measures

Full Information

NCT ID

NCT02777580

First Posted

May 13, 2016

Last Updated

December 20, 2022

Sponsor

KU Leuven

Collaborators

Boehringer Ingelheim, Life Sciences Research Partners, Fund for Clinical Cardiovascular Research at LRD

1. Study Identification

Unique Protocol Identification Number

NCT02777580

Brief Title

STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction

Acronym

STREAM-2

Official Title

STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 1, 2017 (Actual)

Primary Completion Date

October 13, 2022 (Actual)

Study Completion Date

October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

KU Leuven

Collaborators

Boehringer Ingelheim, Life Sciences Research Partners, Fund for Clinical Cardiovascular Research at LRD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction

Keywords

Thrombolytic Therapy, Primary PCI

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

609 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pharmaco-invasive strategy

Arm Type

Experimental

Arm Description

Arm Title

Standard primary PCI

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Tenecteplase

Other Intervention Name(s)

TNKase, Metalyse

Intervention Description

Half dose Tenecteplase

Intervention Type

Drug

Intervention Name(s)

Clopidogrel

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Coronary angiography

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Primary PCI

Intervention Description

Primary PCI accoring to local standards

Primary Outcome Measure Information:

Title

Number of patients achieving ≥ 50 % ST-segment resolution before and after PCI; needing rescue PCI; demonstrating TIMI flow grades (0,1,2,3); with aborted MI.

Time Frame

30 days

Title

Number of patients with stroke (total, intracranial haemorrhage, ischaemic, haemorrhagic conversion) and non-intracranial bleeds. Number of patients with serious cardiac events.

Description

Serious cardiac events (e.g. death , congestive heart failure, reinfarction, resuscitated ventricular fibrillation, repeat target vessel recanalization, stent thrombosis, total AV block etc).

Time Frame

30 days

Title

Composite endpoints (e.g. death, shock, heart failure and recurrent MI) will be assessed as described in the statistical analytical plan.

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age equal or greater than 60 years Onset of symptoms < 3 hours prior to randomisation 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 Informed consent received Exclusion Criteria: 1. Expected performance of PCI < 60 minutes from diagnosis (qualifying ECG) or inability to arrive at the catheterisation laboratory within 3 hours Previous CABG Left bundle branch block or ventricular pacing Patients with cardiogenic shock - Killip Class 4 Patients with a body weight < 55 kg (known or estimated) 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 Known prior stroke or TIA 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) Active bleeding or known bleeding disorder/diathesis 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) 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) Clinical diagnosis associated with increased risk of bleeding including known active peptic ulceration and/or neoplasm with increased bleeding risk Prolonged cardiopulmonary resuscitation (> 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.

Overall Study Officials: