A Novel Strategy For Personalized Long-Term Dual Antiplatelet Therapy (RAPID EXTEND PILOT STUDY)
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| ClinicalTrials.gov Identifier: NCT03224923 |
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Recruitment Status :
Terminated
(Competing study to be started in November 2018)
First Posted : July 21, 2017
Last Update Posted : July 19, 2019
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stable Coronary Syndrome Percutaneous Coronary Intervention Antiplatelet Therapy Ticagrelor | Drug: Ticagrelor 60mg Drug: Clopidogrel 75mg Drug: Aspirin 81 mg | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 5 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Reassessment of Long-Term Dual Anti-Platelet Therapy Using InDividualized Strategies - Using a Novel Combined Demographic and Pharmacogenomic Strategy: The RAPID EXTEND Pilot Study |
| Actual Study Start Date : | August 18, 2017 |
| Actual Primary Completion Date : | September 30, 2018 |
| Actual Study Completion Date : | September 30, 2018 |
| Arm | Intervention/treatment |
|---|---|
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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
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Drug: Ticagrelor 60mg
twice daily Drug: Clopidogrel 75mg once daily Drug: Aspirin 81 mg once daily |
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Active Comparator: Long-Term Ticagrelor
Patients will be given 60mg Ticagrelor twice daily with no aspirin
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Drug: Ticagrelor 60mg
twice daily |
- 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
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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): NCT03224923
| Canada, Ontario | |
| University of Ottawa Heart Institute | |
| Ottawa, Ontario, Canada, K1Y4W7 | |
| Principal Investigator: | Derek So, MD | Ottawa Heart Institute Research Corporation |
| Responsible Party: | Ottawa Heart Institute Research Corporation |
| ClinicalTrials.gov Identifier: | NCT03224923 History of Changes |
| Other Study ID Numbers: |
20170341 |
| First Posted: | July 21, 2017 Key Record Dates |
| Last Update Posted: | July 19, 2019 |
| Last Verified: | July 2019 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Aspirin Clopidogrel Ticagrelor Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents |
Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents |