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Low-Dose tPA in PCI for Heart Attack (STRIVE Trial)
Phase 3
Recruiting
Led By Shamir Mehta, MD
Research Sponsored by Population Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Large thrombus burden with angiographic TIMI Thrombus Grade ≥3 after guidewire crossing
Patients with STEMI undergoing primary PCI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
STRIVE Trial Summary
This trial will test whether using a low dose of the drug tissue plasminogen activator during primary percutaneous coronary intervention (PCI) for patients with ST elevation myocardial infarction (STEMI) can reduce the incidence of post-procedural myocardial blush (MBG) grade 0/1 or distal embolization.
Who is the study for?
This trial is for patients with a severe type of heart attack (STEMI) who can receive treatment within 6 to 12 hours of symptom onset. They must have significant ECG changes and a large clot in the heart's arteries. People at high risk of bleeding, those who've had recent fibrinolytic therapy, or have certain ECG abnormalities cannot join.Check my eligibility
What is being tested?
The STRIVE study tests if adding low-dose tissue plasminogen activator (tPA) during an artery-opening procedure (PCI) can improve blood flow in the heart muscle after STEMI compared to using saline as a control.See study design
What are the potential side effects?
Potential side effects include bleeding complications due to tPA, which helps dissolve clots but may increase bleeding risk elsewhere in the body. Other risks are related to standard PCI procedures.
STRIVE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart condition involves a significant blood clot after a procedure.
Select...
I am receiving a procedure to open blocked arteries after a severe heart attack.
STRIVE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Post-procedural MBG 0/1 or Distal Embolization.
Secondary outcome measures
CV Death, MI, Cardiogenic Shock or New Onset HF
Complete ST-segment resolution.
STRIVE Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Intracoronary tPA 20 mgExperimental Treatment1 Intervention
Group II: Intracoronary tPA 10 mgExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tissue plasminogen activator
2003
Completed Phase 1
~130
Find a Location
Who is running the clinical trial?
Heart and Stroke Foundation of CanadaOTHER
122 Previous Clinical Trials
71,910 Total Patients Enrolled
Population Health Research InstituteLead Sponsor
155 Previous Clinical Trials
679,712 Total Patients Enrolled
Shamir Mehta, MDPrincipal InvestigatorMcMaster University, Hamilton Health Sciences, Population Health Research Institute
1 Previous Clinical Trials
5,100 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a specific heart condition called left bundle branch block which would make it difficult to measure a specific outcome of the study.I was in a state of heart failure when I first sought medical help.My heart condition involves a significant blood clot after a procedure.I have not had any recent internal or brain bleeding.I am receiving a procedure to open blocked arteries after a severe heart attack.Your ECG shows specific changes that indicate a serious heart condition called STEMI.I have received a clot-dissolving medication within the last 24 hours.I have no conditions that prevent me from receiving clot-dissolving treatments.I will be treated with a specific heart medication soon.
Research Study Groups:
This trial has the following groups:- Group 1: Intracoronary tPA 10 mg
- Group 2: Intracoronary tPA 20 mg
- Group 3: Placebo
Awards:
This trial has 1 awards, including:- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants will this research project be able to accommodate?
"Yes, according to the latest information on clinicaltrials.gov, this study is still looking for volunteers. The trial was first posted on 4/1/2018 and was last edited on 7/19/2022. They are hoping to find 200 participants from 1 site."
Answered by AI
How often do adverse reactions occur in patients taking tissue plasminogen activator?
"There is prior clinical data supporting tissue plasminogen activator's safety, so it received a score of 3."
Answered by AI
Are we still enrolling people in this trial?
"That is correct. The trial, which was initially posted on April 1st 2018 as indicated by clinicaltrials.gov, is currently seeking 200 individuals from a single site."
Answered by AI
What other scientific papers have been published on tissue plasminogen activator?
"Tissue plasminogen activator has 16 ongoing Phase 3 trials and 23 active clinical trials in total. Most of the research is conducted in Hollywood, Florida, but there are 419 sites running clinical trials for tissue plasminogen activator globally."
Answered by AI
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