A Pharmacodynamic Study of a Personalized Strategy for P2Y12 Inhibition Versus Ticagrelor in Reducing Ischemic and Bleeding Risk
Information source: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Coronary Syndrome; Percutaneous Coronary Intervention
Intervention: Ticagrelor, Prasugrel, Clopidogrel (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Ottawa Heart Institute Research Corporation Overall contact: Lyne Stuewe, BScN, Phone: 613-761-4646, Email: lstuewe@ottawaheart.ca
Summary
In patients with heart attacks, the treatment of choice is to restore blood flow with
percutaneous coronary intervention (PCI) (use of stents (metal meshes) to open blockages).
After PCI, the standard drug treatment includes aspirin and clopidogrel. These medications
block full function of the platelet cells, which are responsible for clotting. Despite
their use, patients after PCI are at risk for heart attacks, sudden clotting of stents or
death. A major contributor may be resistance to clopidogrel. New more potent drugs, which
can overcome the resistance, are now available; however, they come with an increase chance
of severe bleeding and costs. An ideal solution would be to identify at-risk patients and
selectively treat them with more potent drugs, while lower-risk patients continue with
clopidogrel. This type of strategy (personalized strategy) would decrease heart attacks and
death (compared to clopidogrel), while also preventing bleeding complications (compared to
treating all patients with the new drugs).
Of resistant patients, many carry genes (inherited units) that prevent proper absorption of
clopidogrel. Our group has developed and tested a new bedside genetic test, which
identifies carriers of at-risk genes. However, this technique alone does not identify all
at-risk patients. Consequently, we have now devised a novel tool, which combines genetics
with patient characteristics to identify high-risk patients.
The present study combines this new tool into a strategy for personalized treatment.
Patients with heart attacks who undergo PCI will be randomly assigned to 1 of 3 strategies:
a) new personalized strategy, b) clopidogrel strategy (previous standard drug) or c)
ticagrelor strategy (stronger approved drug). The function of the platelet cells will be
measured at 1 month to determine potential benefits. Evaluation of this new personalized
strategy is important for improving patient outcomes after PCI. The hypothesis is that
patients receiving a personalized strategy will have decrease risk for future heart attacks
and bleeding.
Clinical Details
Official title: Reassessment of Anti-Platelet Therapy Using InDividualized Strategies - Modifying Acute CoroNary Syndrome Algorithms Based on Genetic and Demographic Evaluation: The RAPID-MANAGE Study
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Proportion of Patients in Therapeutic Window
Secondary outcome: P2Y12 Reaction Unit (PRU)Bleeding MACE Stent thrombosis
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients: age >18 yrs, < 75yrs
- > 60 kg ( since March 2015 age >75 and < 60 kg eligible - but prasugrel reduced to
5mg daily if randomized to personalized therapy arm)
- NSTEMI undergoing PCI will be eligible
Exclusion Criteria:
- Patients will be excluded if they have: i) a contra-indication for clopidogrel or
prasugrel or ticagrelor (as per monograph), ii) have an intolerance to aspirin, iii) have
absolute requirement for ticagrelor or prasugrel (e. g. stent thrombosis, allergic reaction
to clopidogrel), iv) requirement for anti-coagulation treatment, v) a history of stroke,
TIA or intracranial hemorrhage , vi) a platelet count < 100,000/μl, vii) a known bleeding
diathesis, viii) hematocrit <30% or >52%, ix) severe liver dysfunction, x) renal
insufficiency (creatinine clearance < 30ml/min), xi) adjuvant therapy with a glycoprotein
IIbIIIa inhibitor.
Locations and Contacts
Lyne Stuewe, BScN, Phone: 613-761-4646, Email: lstuewe@ottawaheart.ca
University of Ottawa Heart Institute, Ottawa, Ontario K1Y4W7, Canada; Recruiting Lyne Stuewe, BScN, Phone: 613-761-4646, Email: lstuewe@ottawaheart.ca Derek So, MD FRCPC FACC, Principal Investigator
Montreal Heart Institute, Montreal, Quebec H1T1C8, Canada; Recruiting Vat Molywan, Email: molywan.vat@mail.mcgill.ca Jean-Francois Tanguay, MD FRCPC, Principal Investigator
Additional Information
Starting date: September 2014
Last updated: March 28, 2015
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