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Trial record 1 of 1 for:    NCT03335839
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Adjunctive, Low-dose tPA in Primary PCI for STEMI (STRIVE)

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ClinicalTrials.gov Identifier: NCT03335839
Recruitment Status : Recruiting
First Posted : November 8, 2017
Last Update Posted : February 28, 2020
Sponsor:
Collaborator:
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
Population Health Research Institute

Tracking Information
First Submitted Date  ICMJE November 3, 2017
First Posted Date  ICMJE November 8, 2017
Last Update Posted Date February 28, 2020
Actual Study Start Date  ICMJE April 1, 2018
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 6, 2017)
Major adverse cardiovascular events [ Time Frame: 180 days ]
Composite of cardiovascular death, myocardial re-infarction or new onset heart failure.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2018)
  • Complete ST-segment resolution. [ Time Frame: 30 minutes ]
    Complete (≥70%) ST-segment resolution (worst lead) at 30 minutes post-PCI
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2017)
  • Complete ST-segment resolution [ Time Frame: 30 minutes ]
    Complete (≥70%) ST-segment resolution (worst lead) at 30 minutes post-PCI
  • All-cause mortality [ Time Frame: 180 days ]
    Death from any cause
  • Stroke [ Time Frame: 180 days ]
  • Cardiovascular death [ Time Frame: 180 days ]
  • Myocardial infarction [ Time Frame: 180 days ]
  • New onset heart failure [ Time Frame: 180 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adjunctive, Low-dose tPA in Primary PCI for STEMI
Official Title  ICMJE Adjunctive, Low-dose Intracoronary Recombinant Tissue Plasminogen Activator (tPA) Versus Placebo for Primary PCI in Patients With ST-segment Elevation Myocardial Infarction
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Myocardial Infarction
  • Percutaneous Coronary Intervention
Intervention  ICMJE
  • Drug: tissue plasminogen activator
    Recombinant tPA is a fibrin-specific 2nd generation plasminogen activator and thrombolytic drug.
  • Other: Saline
    Placebo
Study Arms  ICMJE
  • Experimental: Intracoronary tPA 10 mg
    Intervention: Drug: tissue plasminogen activator
  • Experimental: Intracoronary tPA 20 mg
    Intervention: Drug: tissue plasminogen activator
  • Placebo Comparator: Placebo
    saline
    Intervention: Other: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 23, 2018)
200
Original Estimated Enrollment  ICMJE
 (submitted: November 6, 2017)
4000
Estimated Study Completion Date  ICMJE December 1, 2020
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Brandi Meeks, MSc 9055274322 strive@phri.ca
Contact: Sabine Brett, MSc 9055274322 strive@phri.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03335839
Other Study ID Numbers  ICMJE STRIVE.2018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Population Health Research Institute
Study Sponsor  ICMJE Population Health Research Institute
Collaborators  ICMJE Heart and Stroke Foundation of Canada
Investigators  ICMJE
Principal Investigator: Shamir Mehta, MD McMaster University, Hamilton Health Sciences, Population Health Research Institute
PRS Account Population Health Research Institute
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP