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
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