Adjunctive, Low-dose tPA in Primary PCI for STEMI (NCT03335839) | Clinical Trial Compass
CompletedPhase 3
Adjunctive, Low-dose tPA in Primary PCI for STEMI
Canada210 participantsStarted 2018-04-01
Plain-language summary
STRIVE will evaluate the use of adjunctive, low-dose intracoronary tissue plasminogen activator during primary percutaneous coronary intervention (PCI) for patients with ST elevation myocardial infarction (STEMI) in reducing the incidence of post-procedural myocardial blush (MBG) grade 0/1 or distal embolization.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with STEMI undergoing primary PCI and,
. ECG changes indicating large territory STEMI (defined as ≥2mm ST-segment elevation in 2 contiguous anterior precordial leads; or ≥2mm ST-segment elevation in 2 inferior leads coupled with ST-segment depression in 2 contiguous anterior leads for a total ST-segment deviation of ≥8mm) and,
. Randomization within 6 to 12 hours of symptom onset and,
. Large thrombus burden with angiographic TIMI Thrombus Grade ≥3 after guidewire crossing.
Exclusion criteria
. Active internal bleeding or high risk of bleeding or any prior intracranial bleeding.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested adding low-dose tPA — a clot-dissolving drug — on top of the standard primary PCI procedure for a heart attack; given that tPA carries a bleeding risk, can you help me understand whether the potential benefit of better blood flow to the heart muscle was worth that added risk based on what this study found?
2The trial measured something called Myocardial Blush Grade, which reflects how well blood actually reaches the heart muscle after the artery is opened — is my situation one where poor blood flow to the heart muscle tissue is a concern, and would that make the findings from this trial relevant to my case?
3Since this was a Phase 3 trial and recruitment is now completed, does that mean there are results available, and if so, what did they show about whether adding low-dose tPA reduced serious complications like distal embolization or major cardiac events compared to standard PCI alone?
4Standard primary PCI is already the guideline treatment for a STEMI — given that this trial was testing an add-on approach to that standard care, do you think the results suggest any reason to consider this combined strategy over PCI by itself for someone in my specific situation?
5This trial tracked whether patients achieved at least 50% ST-segment resolution on their EKG after treatment, which signals how well the heart is recovering — can you explain what my own EKG results showed, and whether that outcome measure from this trial is something worth factoring into decisions about my care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
MACE OR Myocardial Blush Grade 0/1 OR Distal Embolization OR Failure to Achieve ≥50% ST-segment Resolution