A Clinical Study of Safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel in Vietnamese Patient

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-04-30

Brief Summary

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Study in Vietnamese Patients with Coronary Heart Disease to investigate safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel

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Detailed Description

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Safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel in Vietnamese Patients with Coronary Heart Disease: A Randomized, Open Label, Crossover Study

Conditions

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Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Ticagrelor

90 mg Ticagrelor

Group Type EXPERIMENTAL

90 mg Ticagrelor

Intervention Type DRUG

Morning and Evening dose for 5 days

Clopidogrel

75mg Clopidogrel

Group Type ACTIVE_COMPARATOR

75mg Clopidogrel

Intervention Type DRUG

Morning dose for 5 days

Interventions

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90 mg Ticagrelor

Morning and Evening dose for 5 days

Intervention Type DRUG

75mg Clopidogrel

Morning dose for 5 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female Vietnamese patients (as confirmed by the Principal Investigator) aged \>18 years with suitable veins for cannulations or repeated venipunctures and stable coronary heart disease
* Stable use of aspirin 75 to 100 mg daily for at least the preceding 2 weeks and which will be continued throughout the study period
* Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive
* Women must have a negative urine pregnancy test at Visit 1

Exclusion Criteria

* History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study
* Unstable angina or any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IP
* Patients who had acute coronary syndrome or stent placed within 12 months of screening
* Planned arterial revascularization
* Current use of ADP receptor blockers (eg, clopidogrel, ticlopidine, prasugrel), dipyridamole or cilostazol

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No