Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Novel Strategy For Personalized Long-Term Dual Antiplatelet Therapy (RAPID EXTEND PILOT STUDY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03224923
Recruitment Status : Terminated (Competing study to be started in November 2018)
First Posted : July 21, 2017
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

Tracking Information
First Submitted Date  ICMJE July 14, 2017
First Posted Date  ICMJE July 21, 2017
Last Update Posted Date July 19, 2019
Actual Study Start Date  ICMJE August 18, 2017
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2017)
Proportion of Patients with Decreased Bleeding Risk [ Time Frame: 1 month ]
The primary endpoint is the proportion of patients with low on-treatment platelet reactivity (LPR) in the PA group compared to the LTT group at 1 month.
  • P2Y12 reactivity units (PRU) as a continuous variable will be measured using a VerifyNow P2Y12 assay
  • a PRU value of < 85 is associated with increased bleeding risk
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03224923 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2017)
  • Platelet Reactivity Index (PRI) as a continuous variable [ Time Frame: 1 month ]
    Platelet function as measured by Vasodilator-stimulated phosphoprotein (VASP)
    • a PRI of < 16% is associated with increased bleeding risk
  • ADP-induced Aggregation (AU) as a continuous variable [ Time Frame: 1 month ]
    Platelet function as measured by Multiplate analyzer
    • an AU of < 19 is associated with increased bleeding risk
  • Bleeding according to Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 1 month, 6 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years ]
    the incidence and severity of bleeding as defined by BARC classification system
  • Bleeding according to Thrombolysis in Myocardial Infarction (TIMI) score [ Time Frame: 1 month, 6 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years ]
    the incidence and severity of bleeding as defined by TIMI classification systems
  • Bleeding according to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) criteria [ Time Frame: 1 month, 6 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years ]
    the incidence and severity of bleeding as defined by GUSTO classification systems
  • Ischemic Endpoints (To be collected but blinded to investigators, as this data will be carried from the pilot study into a future definitive clinical trial). [ Time Frame: 1 month, 6 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years ]
    all-cause mortality incidence
  • Ischemic Endpoints (To be collected but blinded to investigators, as this data will be carried from the pilot study into a future definitive clinical trial). [ Time Frame: 1 month, 6 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years ]
    recurrent myocardial infarction (MI) incidence
  • Ischemic Endpoints (To be collected but blinded to investigators, as this data will be carried from the pilot study into a future definitive clinical trial). [ Time Frame: 1 month, 6 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years ]
    stroke incidence
  • Ischemic Endpoints (To be collected but blinded to investigators, as this data will be carried from the pilot study into a future definitive clinical trial). [ Time Frame: 1 month, 6 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years ]
    stent thrombosis incidence
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 19, 2017)
  • Cost [ Time Frame: 1 month, 6 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years ]
    Evaluate cost involved in each strategy
  • Genetic factors associated to outcomes [ Time Frame: 1 month, 6 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years ]
    Exploratory analysis of other potential genetic variants to outcomes
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Novel Strategy For Personalized Long-Term Dual Antiplatelet Therapy (RAPID EXTEND PILOT STUDY)
Official Title  ICMJE Reassessment of Long-Term Dual Anti-Platelet Therapy Using InDividualized Strategies - Using a Novel Combined Demographic and Pharmacogenomic Strategy: The RAPID EXTEND Pilot Study
Brief Summary

In patients with heart attacks, the current standard of care is to restore blood flow through percutaneous coronary intervention (PCI). This is done using stents (metal meshes) that opens up blockages. Following PCI, standard preventative drug treatment includes the use of dual antiplatelet therapy (DAPT) using both aspirin and a platelet P2Y12 receptor inhibitor (Ticagrelor 90 mg twice a day or Clopidogrel 75 mg once a day) for one year to prevent clotting that can result in additional heart attacks, sudden clotting of stents or death.

New studies have shown that there is a benefit to continuing DAPT beyond this one year mark. Longer-term DAPT has been shown to reduce ischemic events (heart attack, stroke) but increase the risk of bleeding. Present guidelines state that the decision to continue DAPT beyond the one year mark should be made on an individualized basis.

The present study is a "pilot study" that seeks to compare Long-Term use of Ticagrelor (LTT) versus a Personalized Approach (PA). We will be recruiting patients who have been stable (free of ischemic or bleeding outcomes) on DAPT for 1 year after initial presentation with a heart attack.

The PA group will use a modified DAPT score based on patient demographics to decide whether treatment is warranted. Patient will also undergo bedside genetic testing to identify potential at-risk genes. Those identified as carriers will be treated with ticagrelor while non-carriers will be treated with clopidogrel.

The present study will determine whether a personalized approach will decrease bleeding versus an approach of universal ticagrelor use.

The hypothesis is that patients receiving a personalized strategy will have a decreased risk of bleeding.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Stable Coronary Syndrome
  • Percutaneous Coronary Intervention
  • Antiplatelet Therapy
  • Ticagrelor
Intervention  ICMJE
  • Drug: Ticagrelor 60mg
    twice daily
  • Drug: Clopidogrel 75mg
    once daily
  • Drug: Aspirin 81 mg
    once daily
Study Arms  ICMJE
  • Experimental: Personalized Treatment Algorithm

    A DAPT score using various patient demographics will be calculated:

    If score under 2, patients will receive only aspirin 81 mg once daily

    If DAPT score is ≥ 2

    • A point-of-care bedside genetic test using a buccal swab will be conducted in order to determine medication regimen
    • Those with a positive genetic test (presence of CYP2C19*2 or CYP2C19*3), will receive 60mg Ticagrelor twice daily
    • Those with a negative genetic test (absence of CYP2C19*2/*3) will receive 75mg clopidogrel once daily
    Interventions:
    • Drug: Ticagrelor 60mg
    • Drug: Clopidogrel 75mg
    • Drug: Aspirin 81 mg
  • Active Comparator: Long-Term Ticagrelor
    Patients will be given 60mg Ticagrelor twice daily with no aspirin
    Intervention: Drug: Ticagrelor 60mg
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 Terminated
Actual Enrollment  ICMJE
 (submitted: October 4, 2018)
5
Original Estimated Enrollment  ICMJE
 (submitted: July 19, 2017)
70
Actual Study Completion Date  ICMJE September 30, 2018
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • non-ST-elevation myocardial infarction (NSTEMI) or ST-elevation myocardial infarction (STEMI) at presentation for index PCI who have successfully completed >1-year follow-up of RAPID MANAGE or TAILOR-PCI trials without having incurred an ischemic or bleeding outcome while on DAPT
  • Patients with DAPT interruption after 1 year will be eligible, if within 3 years of index MI

Patients must also have 1 of the following atherothrombotic risk enrichment criteria:

  • age ≥ 65 years
  • diabetes
  • 2nd prior MI (> 1 year ago)
  • multi-vessel coronary disease
  • Creatinine Clearance < 60mL/min

Exclusion Criteria:

Patients will be excluded from the study if they:

  • refuse consent
  • are > 3 years post MI
  • are deemed to require a P2Y12 inhibitor
  • require oral anticoagulation
  • have a history of stroke, transient ischemic attack (TIA) or intracranial bleed
  • have had a recent GI bleed or major surgery
  • have a life expectancy of < 1 year
  • have a platelet count < 100,000/μl
  • have a bleeding diathesis
  • have hematocrit < 30% or > 52%
  • are on dialysis or have severe liver disease
  • are at risk for bradycardia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03224923
Other Study ID Numbers  ICMJE 20170341
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 Not Provided
Responsible Party Ottawa Heart Institute Research Corporation
Study Sponsor  ICMJE Ottawa Heart Institute Research Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Derek So, MD Ottawa Heart Institute Research Corporation
PRS Account Ottawa Heart Institute Research Corporation
Verification Date July 2019

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