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Antiplatelet Agent
Tenecteplase for Heart Attack (STREAM-2 Trial)
Phase 4
Waitlist Available
Led By Peter Sinnaeve, MD, PhD
Research Sponsored by KU Leuven
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial compares two treatments for heart attack patients aged 60 and older. One treatment uses medications to dissolve clots and prevent new ones, followed by procedures if needed. The other treatment uses a procedure to open blocked arteries directly. The goal is to determine which approach is safer and more effective.
Eligible Conditions
- Heart Attack
- Heart Failure
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Successful Reperfusion
Total Stroke
Side effects data
From 2023 Phase 4 trial • 609 Patients • NCT027775805%
cardiogenic shock
4%
heart failure
2%
reinfarction
1%
cardiac arrest
1%
Pneumonia
1%
pulseless electrical activity
1%
atrial fibrillation
1%
coronary arterial dissection
1%
major nonintracranial bleeding
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Primary PCI
Pharmaco-invasive Strategy
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Pharmaco-invasive strategyExperimental Treatment3 Interventions
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.
Group II: Standard primary PCIActive Control1 Intervention
Primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tenecteplase
FDA approved
Clopidogrel
FDA approved
Coronary angiography
2010
Completed Phase 4
~24230
Find a Location
Who is running the clinical trial?
KU LeuvenLead Sponsor
570 Previous Clinical Trials
200,332,731 Total Patients Enrolled
Boehringer IngelheimIndustry Sponsor
2,548 Previous Clinical Trials
14,400,692 Total Patients Enrolled
Life Sciences Research PartnersUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition called left bundle branch block or ventricular pacing.You have received prolonged CPR (more than 2 minutes) within the last 2 weeks.You have a current or recent infection in your heart or the tissue around it.You have a medical condition that increases your risk of bleeding, such as a current peptic ulcer or a cancer that can cause bleeding.You have dementia, a condition that affects your memory and thinking abilities.You have severe heart problems that put you at risk of heart failure.You have had a previous stroke or mini-stroke (TIA).You are currently experiencing bleeding or have a known bleeding disorder.You are allergic to tenecteplase, clopidogrel, enoxaparin, or aspirin.You have had previous damage to your brain or spine, such as a tumor, surgery, or recent head injury within the past three months.
Research Study Groups:
This trial has the following groups:- Group 1: Pharmaco-invasive strategy
- Group 2: Standard primary PCI
Awards:
This trial has 5 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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