Myocardial InfarctionPhase 3STRIVENCT03335839
Adjunctive, Low-dose tPA in Primary PCI for STEMI
A Phase 3 study testing tissue plasminogen activator and Saline in people with Myocardial Infarction and Percutaneous Coronary Intervention, run by Population Health Research Institute at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Percutaneous Coronary Intervention
- What is being tested?
- tissue plasminogen activator and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Apr 2018to 12 Feb 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Active internal bleeding or high risk of bleeding or any prior intracranial bleeding.
- Any other absolute or relative contraindication to fibrinolytic therapy.
- Administration of a fibrinolytic ≤24hrs prior to randomization.
- Cardiogenic shock on presentation.
- Left bundle branch block (excluded because the ECG cannot be evaluated for ST segment resolution, an outcome of the study).
- Planned upfront use of a glycoprotein IIb/IIIa inhibitor.
- Any medical, geographic, or social factor making study participation impractical or precluding 1 month follow-up.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
University of Calgary - Foothills Medical Centre
Calgary, Alberta, T2N 4Z6
University of Alberta - Mazankowski Alberta Heart Insitute
Edmonton, Alberta, T6G 2B7
Hamilton General Hospital
Hamilton, Ontario, L8L2X2
About this study
Official title: Adjunctive, Low-dose Intracoronary Recombinant Tissue Plasminogen Activator (tPA) Versus Placebo for Primary PCI in Patients With ST-segment Elevation Myocardial Infarction
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.
Read the detailed description
STRIVE is a prospective, 3-arm, parallel group, blinded, randomized controlled trial evaluating the efficacy of a novel approach to prevent and treat microvascular obstruction thereby reducing major cardiovascular events using intracoronary administration of very low-dose fibrinolytic (tissue plasminogen activator, tPA) directly into the culprit coronary artery during primary PCI.
- Being tested
- tissue plasminogen activator, Saline
- Keywords
- tPA
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tissue plasminogen activatorDrug
Recombinant tPA is a fibrin-specific 2nd generation plasminogen activator and thrombolytic drug.
SalineOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Intracoronary tPA 10 mg | Experimental | Not described Receives: Drug: tissue plasminogen activator |
| Intracoronary tPA 20 mg | Experimental | Not described Receives: Drug: tissue plasminogen activator |
| Placebo | Placebo comparator | saline Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE OR Myocardial Blush Grade 0/1 OR Distal Embolization OR Failure to Achieve ≥50% ST-segment Resolution
The primary efficacy variable is the binary composite outcome with the following components:
- The occurrence of any of the MACE outcomes (cardiovascular death, myocardial re-infarction, cardiogenic shock and new onset heart failure) at 30 days post-randomization.
- Post-procedural Myocardial Blush Grade of either 0 (Failure of dye to enter the microvasculature or persistent "staining", suggesting leakage of the contrast medium into the extravascular space) or 1 (Dye enters slowly but fails to exit the microvasculature. Dye is present in the next injection (30 seconds)).
- Post-procedural Distal embolization, defined as distal filling defect with an abrupt 'cut-off' in one of the peripheral coronary branches of the infarct related artery, distal to the angioplasty site following PCI).
- Failure to achieve ≥50% ST-segment resolution post-procedure.
Measured: 30 days post-randomization
Secondary outcomes (6)
The Composite of MBG grade 0/1 or Distal Embolization or Failure to Achieve ≥50% ST-segment Resolution
- Post-procedural Myocardial Blush Grade of either 0 (Failure of dye to enter the microvasculature or persistent "staining", suggesting leakage of the contrast medium into the extravascular space) or 1 (Dye enters slowly but fails to exit the microvasculature. Dye is present in the next injection (30 seconds)).
- Post-procedural Distal embolization, defined as distal filling defect with an abrupt 'cut-off' in one of the peripheral coronary branches of the infarct related artery, distal to the angioplasty site following PCI).
- Failure to achieve ≥50% ST-segment resolution post-procedure of the summed absolute ST-segment deviations across associated and reciprocal leads at 30 minutes post-PCI
Measured: 30 minutes post-PCI
The Composite of MBG grade 0/1 or Distal Embolization
- Post-procedural Myocardial Blush Grade of either 0 (Failure of dye to enter the microvasculature or persistent "staining", suggesting leakage of the contrast medium into the extravascular space) or 1 (Dye enters slowly but fails to exit the microvasculature. Dye is present in the next injection (30 seconds)).
- Post-procedural Distal embolization, defined as distal filling defect with an abrupt 'cut-off' in one of the peripheral coronary branches of the infarct related artery, distal to the angioplasty site following PCI).
Measured: Immediately following PCI
MBG Grade 0/1
Post-procedural Myocardial Blush Grade of either 0 (Failure of dye to enter the microvasculature or persistent "staining", suggesting leakage of the contrast medium into the extravascular space) or 1 (Dye enters slowly but fails to exit the microvasculature. Dye is present in the next injection (30 seconds)).
Measured: Immediately following PCI
Distal Embolization
Post-procedural distal embolization, defined as distal filling defect with an abrupt 'cut-off' in one of the peripheral coronary branches of the infarct related artery, distal to the angioplasty site following PCI.
Measured: Immediately following PCI
Failure to Achieve ≥50% ST-segment Resolution.
Failure to achieve ≥50% ST-segment resolution of the summed absolute ST-segment deviations across associated and reciprocal leads at 30 minutes post-PCI.
Measured: 30 minutes post-PCI
Time to the First Occurrence of MACE
Time to the first occurrence of MACE (composite of cardiovascular death, myocardial re-infarction, cardiogenic shock or new onset heart failure) over the duration of 30 days follow-up.
Measured: 30 days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start1 Apr 2018
- Primary completion17 Sep 2024
- Study completion12 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Responsible party
- Sponsor
- Investigators
- Shamir Mehta, MD, Principal investigator, McMaster University, Hamilton Health Sciences, Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335839
- Sponsor's protocol ID
- STRIVE.2018
- Acronym
- STRIVE
- Status last verified
- Jun 2026
- First submitted
- 3 Nov 2017
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mehta SR, Pinilla-Echeverri N, Tiong D, Kovalova T, Sheth T, Natarajan MK, Sibbald M, Velianou JL, Welsh R, Har B, Jolly SS, Valettas N, Schwalm JD, Tsang M, Khatun R, Mian R, Cunningham J, Ly E, McCready T, Bainey KR. Intracoronary Low-Dose Recombinant Tissue Plasminogen Activator in Primary PCI for ST-Segment Elevation Myocardial Infarction and Large Thrombus Burden: A Randomized Trial. J Am Coll Cardiol. 2026 Jan 27;87(3):238-248. doi: 10.1016/j.jacc.2025.10.008. Epub 2025 Oct 28.
PubMed 41194755
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive, Low-dose Intracoronary Recombinant Tissue Plasminogen Activator (tPA) Versus Placebo for Primary PCI in Patients With ST-segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03335839
- Acronym / sponsor ID
- STRIVE / STRIVE.2018
- Keywords
- tPA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 17 Sep 2024 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 8 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
STRIVE is a prospective, 3-arm, parallel group, blinded, randomized controlled trial evaluating the efficacy of a novel approach to prevent and treat microvascular obstruction thereby reducing major cardiovascular events using intracoronary administration of very low-dose fibrinolytic (tissue plasminogen activator, tPA) directly into the culprit coronary artery during primary PCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intracoronary tPA 10 mg | Experimental | Drug: tissue plasminogen activator |
| Intracoronary tPA 20 mg | Experimental | Drug: tissue plasminogen activator |
| Placebo | Placebo comparator | Other: Salinesaline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Active internal bleeding or high risk of bleeding or any prior intracranial bleeding.
- Any other absolute or relative contraindication to fibrinolytic therapy.
- Administration of a fibrinolytic ≤24hrs prior to randomization.
- Cardiogenic shock on presentation.
- Left bundle branch block (excluded because the ECG cannot be evaluated for ST segment resolution, an outcome of the study).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tissue plasminogen activatorRecombinant tPA is a fibrin-specific 2nd generation plasminogen activator and thrombolytic drug. | Drug | Intracoronary tPA 10 mg, Intracoronary tPA 20 mg |
| SalinePlacebo | Other | Placebo |
Primary outcome
MACE OR Myocardial Blush Grade 0/1 OR Distal Embolization OR Failure to Achieve ≥50% ST-segment Resolution
Time frame: 30 days post-randomization
The primary efficacy variable is the binary composite outcome with the following components: * The occurrence of any of the MACE outcomes (cardiovascular death, myocardial re-infarction, cardiogenic shock and new onset heart failure) at 30 days post-randomization. * Post-procedural Myocardial Blush Grade of either 0 (Failure of dye to enter the microvasculature or persistent "staining", suggesting leakage of the contrast medium into the extravascular space) or 1 (Dye enters slowly but fails to exit the microvasculature. Dye is present in the next injection (30 seconds)). * Post-procedural Distal embolization, defined as distal filling defect with an abrupt 'cut-off' in one of the peripheral coronary branches of the infarct related artery, distal to the angioplasty site following PCI). * Failure to achieve ≥50% ST-segment resolution post-procedure.
6 secondary outcomes
The Composite of MBG grade 0/1 or Distal Embolization or Failure to Achieve ≥50% ST-segment Resolution
Time frame: 30 minutes post-PCI
The Composite of MBG grade 0/1 or Distal Embolization
Time frame: Immediately following PCI
MBG Grade 0/1
Time frame: Immediately following PCI
Distal Embolization
Time frame: Immediately following PCI
Failure to Achieve ≥50% ST-segment Resolution.
Time frame: 30 minutes post-PCI
Time to the First Occurrence of MACE
Time frame: 30 days post-randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Derived from this study: PubMed 41194755Mehta SR, Pinilla-Echeverri N, Tiong D, Kovalova T, Sheth T, Natarajan MK, Sibbald M, Velianou JL, Welsh R, Har B, Jolly SS, Valettas N, Schwalm JD, Tsang M, Khatun R, Mian R, Cunningham J, Ly E, McCready T, Bainey KR. Intracoronary Low-Dose Recombinant Tissue Plasminogen Activator in Primary PCI for ST-Segment Elevation Myocardial Infarction and Large Thrombus Burden: A Randomized Trial. J Am Coll Cardiol. 2026 Jan 27;87(3):238-248. doi: 10.1016/j.jacc.2025.10.008. Epub 2025 Oct 28.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shamir Mehta, MD principal investigator
McMaster University, Hamilton Health Sciences, Population Health Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tissue plasminogen activator and Saline in people with Myocardial Infarction and Percutaneous Coronary Intervention, run by Population Health Research Institute at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE OR Myocardial Blush Grade 0/1 OR Distal Embolization OR Failure to Achieve ≥50% ST-segment Resolution (time frame: 30 days post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03335839, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.