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Adjunctive, Low-dose tPA in Primary PCI for STEMI (STRIVE)

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ClinicalTrials.gov Identifier: NCT03335839
Recruitment Status : Active, not recruiting
First Posted : November 8, 2017
Last Update Posted : October 25, 2018
Sponsor:
Collaborator:
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
Population Health Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Percutaneous Coronary Intervention Drug: tissue plasminogen activator Other: Saline Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adjunctive, Low-dose Intracoronary Recombinant Tissue Plasminogen Activator (tPA) Versus Placebo for Primary PCI in Patients With ST-segment Elevation Myocardial Infarction
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Alteplase

Arm Intervention/treatment
Experimental: Intracoronary tPA 10 mg Drug: tissue plasminogen activator
Recombinant tPA is a fibrin-specific 2nd generation plasminogen activator and thrombolytic drug.

Experimental: Intracoronary tPA 20 mg Drug: tissue plasminogen activator
Recombinant tPA is a fibrin-specific 2nd generation plasminogen activator and thrombolytic drug.

Placebo Comparator: Placebo
saline
Other: Saline
Placebo




Primary Outcome Measures :
  1. Post-procedural MBG 0/1 or Distal Embolization. [ Time Frame: 30 days ]
    Composite of post-procedural myocardial blush (MBG) grade 0/1 or distal embolization.


Secondary Outcome Measures :
  1. Complete ST-segment resolution. [ Time Frame: 30 minutes ]
    Complete (≥70%) ST-segment resolution (worst lead) at 30 minutes post-PCI

  2. CV Death, MI, Cardiogenic Shock or New Onset HF [ Time Frame: 30 Days ]
    Composite of cardiovascular death, myocardial re-infarction, cardiogenic shock or new onset heart failure.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with STEMI undergoing primary PCI and,
  2. 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,
  3. Randomization within 6 to 12 hours of symptom onset and,
  4. Large thrombus burden with angiographic TIMI Thrombus Grade ≥3 after guidewire crossing.

Exclusion Criteria:

  1. Active internal bleeding or high risk of bleeding or any prior intracranial bleeding.
  2. Any other absolute or relative contraindication to fibrinolytic therapy.
  3. Administration of a fibrinolytic ≤24hrs prior to randomization.
  4. Cardiogenic shock on presentation.
  5. Left bundle branch block (excluded because the ECG cannot be evaluated for ST segment resolution, an outcome of the study).
  6. Planned upfront use of a glycoprotein IIb/IIIa inhibitor.
  7. Any medical, geographic, or social factor making study participation impractical or precluding 1 month follow-up.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335839


Locations
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L2X2
Sponsors and Collaborators
Population Health Research Institute
Heart and Stroke Foundation of Canada
Investigators
Principal Investigator: Shamir Mehta, MD McMaster University, Hamilton Health Sciences, Population Health Research Institute

Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT03335839     History of Changes
Other Study ID Numbers: STRIVE.2018
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Population Health Research Institute:
tPA

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Plasminogen
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action