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Transition From Ticagrelor to Clopidogrel Following Acute Coronary Syndrome: To Bolus or Not?

Information source: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Coronary Syndrome

Intervention: Clopidogrel (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Ottawa Heart Institute Research Corporation

Official(s) and/or principal investigator(s):
Derek So, MD, Principal Investigator, Affiliation: Ottawa Heart Institute Research Corporation

Summary

After a heart attack patients are routinely started on drugs to inhibit platelets. Ticagrelor is a powerful anti-platelet drug with clinical benefits. However it must be discontinued in some, because of increased risk of bleeding or intolerance. These patients need to be transitioned to another agent, such as Clopidogrel. At present, there is no clinical consensus on the optimal strategy for this switch. Some clinicians elect to give a bolus dose of clopidogrel with 600mg, while others start directly with a 75mg daily dose, with no evidence regarding the benefits or potential complications associated with each strategy. The present proposal will evaluate the pharmacodynamics of 2 strategies with specialized platelet function testing. We hypothesize that a bolus dose of clopidogrel during the switch will confer better ischemic protection without increasing bleeding risk for patients undergoing a switch in therapy.

Clinical Details

Official title: Transition From Ticagrelor to Clopidogrel Following Acute Coronary Syndrome: To Bolus or Not? The CAPITAL OPTI-CROSS Study.

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Platelet inhibition as assessed by P2Y12 reaction Unit (PRU) after transition from Ticagrelor to Clopidogrel.

Secondary outcome: The difference in platelet inhibition (as expresses as PRU) between the two groups at specified time points.

Detailed description: The overall objective is to evaluate the need for a clopidogrel bolus dose among patients being switched from a regimen of ticagrelor to clopidogrel. In a randomized pharmacodynamics study of 48 patients, we will conduct serial measurements of platelet function/inhibition using the Accumetrics Verifynow assay (platelet inhibition will be expressed as P2Y12 reaction unit [PRU]). Platelet inhibition will be assessed at specific time points over the first 72 hours following the change in medications, which will enable us to determine whether patients in the 2 different strategies may be at increased ischemic or bleeding risks. We hypothesize that a bolus dose of clopidogrel during the switch will confer better ischemic protection without increasing bleeding risk for patients undergoing a switch in therapy. SPECIFIC AIMS: 1. Primary Aim: To determine with platelet function testing the pharmacodynamics effects of a 600mg bolus dose of clopidogrel compared with no bolusing among patients being switched from ticagrelor to clopidogrel. 2. To determine if patients receiving a clopidogrel bolus have improvement in ischemic protection relative to patients without a bolus dose. 3. To determine if patients receiving a clopidogrel bolus may be exposed to increase bleeding risk relative to those without a bolus dose.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- age > 18,

- admission for acute coronary syndrome,

- on dual anti-platelet therapy (including ticagrelor)

- Being transitioned to clopidogrel by their treating physician

- provided informed consent

Exclusion Criteria:

- Bleeding/intolerance to clopidogrel

- Thrombocytopenia (platelet count < 100, 000 per uL)

- Hematocrit <30% or >52%

- treatment with glycoprotein IIb/IIIa inhibitor, 24 hours prior to randomization

Locations and Contacts

University of Ottawa Heart Institute, Ottawa, Ontario K1Y 4W7, Canada
Additional Information

Starting date: December 2013
Last updated: March 28, 2015

Page last updated: August 23, 2015

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