DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017