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| Name | Class |
|---|---|
| Heart and Stroke Foundation of Canada | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intracoronary tPA 10 mg | Experimental |
| |
| Intracoronary tPA 20 mg | Experimental |
| |
| Placebo | Placebo Comparator | saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tissue plasminogen activator | Drug | Recombinant tPA is a fibrin-specific 2nd generation plasminogen activator and thrombolytic drug. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 30 days post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| The Composite of MBG grade 0/1 or Distal Embolization or Failure to Achieve ≥50% ST-segment Resolution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to the First Occurrence of Major Bleeding Over the Duration of 30 Days Follow-up | Clinically overt, bleeding with at least one of the following criteria:
|
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shamir Mehta, MD | McMaster University, Hamilton Health Sciences, Population Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary - Foothills Medical Centre | Calgary | Alberta | T2N 4Z6 | Canada | ||
| University of Alberta - Mazankowski Alberta Heart Insitute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41194755 | Derived | 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. |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Saline | Other | Placebo |
|
| 30 minutes post-PCI |
| The Composite of MBG grade 0/1 or Distal Embolization |
| 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)). | 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. | 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. | 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. | 30 days post-randomization |
| 30 days post-randomization |
| Time to the First Occurrence of Major or Clinically Significant Bleeding Over the Duration of 30 Days Follow-up | Clinically overt, bleeding with at least one of the following criteria:
| 30 days post-randomization |
| Failure to achieve ≥ 50% resolution | Failure to achieve ≥ 50% resolution of the ST-segment value (worst lead) at 30 minutes post-PCI | 30 minutes post-PCI |
| All-Cause Mortality at 30 Days | The composite of cardiovascular or non-cardiovascular death | 30 days post-randomization |
| Flow Velocity as Measured by the Corrected TIMI Frame Count (Continuous) | Continuous measure of TIMI frame count as reported by Angiographic Core Lab. | Immediately following PCI |
| Post-Procedural TIMI Flow Grade 3 | Full perfusion of the infarct vessel with normal flow. | Immediately following PCI |
| Time to the First Occurrence of Composite of Cardiovascular Death (CV), Cardiogenic Shock and New Onset Heart Failure (HF) Over the Duration of 30 Days Follow-up | All deaths with a CV or unknown cause will be classified as CV. Only deaths due to a documented non-CV cause will be classified as non-CV. At least one of the following:
| 30 days post-randomization |
| Edmonton |
| Alberta |
| T6G 2B7 |
| Canada |
| Hamilton General Hospital | Hamilton | Ontario | L8L2X2 | Canada |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |