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

Percutaneous Coronary Intervention Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03224923
• Other study ID #: 20170341
• Status: Terminated
• Phase: Phase 4
• Start date: August 18, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: July 2019
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antiplatelet Therapy
• Percutaneous Coronary Intervention
• Stable Coronary Syndrome
• Ticagrelor

Intervention

Drug:
• Ticagrelor 60mg
twice daily
• Clopidogrel 75mg
once daily
• Aspirin 81 mg
once daily

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost	Evaluate cost involved in each strategy	1 month, 6 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years
Other	Genetic factors associated to outcomes	Exploratory analysis of other potential genetic variants to outcomes	1 month, 6 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years
Primary	Proportion of Patients with Decreased Bleeding Risk	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	1 month
Secondary	Platelet Reactivity Index (PRI) as a continuous variable	Platelet function as measured by Vasodilator-stimulated phosphoprotein (VASP); a PRI of < 16% is associated with increased bleeding risk	1 month
Secondary	ADP-induced Aggregation (AU) as a continuous variable	Platelet function as measured by Multiplate analyzer; an AU of < 19 is associated with increased bleeding risk	1 month
Secondary	Bleeding according to Bleeding Academic Research Consortium (BARC) criteria	the incidence and severity of bleeding as defined by BARC classification system	1 month, 6 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years
Secondary	Bleeding according to Thrombolysis in Myocardial Infarction (TIMI) score	the incidence and severity of bleeding as defined by TIMI classification systems	1 month, 6 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years
Secondary	Bleeding according to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) criteria	the incidence and severity of bleeding as defined by GUSTO classification systems	1 month, 6 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years
Secondary	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).	all-cause mortality incidence	1 month, 6 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years
Secondary	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).	recurrent myocardial infarction (MI) incidence	1 month, 6 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years
Secondary	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).	stroke incidence	1 month, 6 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years
Secondary	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).	stent thrombosis incidence	1 month, 6 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years