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

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01757262
• Other study ID #: D5130C00078
• Status: Withdrawn
• Phase: Phase 3
• First received: December 21, 2012
• Last updated: May 10, 2013
• Start date: January 2013
• Est. completion date: April 2013

Study information

• Verified date: May 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of Health - Vietnam
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• 90 mg Ticagrelor
Morning and Evening dose for 5 days
• 75mg Clopidogrel
Morning dose for 5 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacodynamics of Ticagrelor on P2Y12 receptor blockade measured by the VerifyNow P2Y12 assay[expressed as P2Y12 reaction units (PRU)]		Day 1 pre-dose and at 0 (pre-dose), 1, 2, 8, 12 and 24 hours post morning dose on Day 5	No
Primary	Pharmacodynamics of Clopidogrel P2Y12 receptor blockade measured by the VerifyNow P2Y12 assay[expressed as P2Y12 reaction units (PRU)]		Day 1 pre-dose and at 0 (pre-dose), 1, 2, 8, 12 and 24 hours post morning dose on Day 5	No
Secondary	Safety profile in terms of adverse events, blood pressure, pulse, ECG (Electrocardiogram), physical examination, and safety laboratory variables		From screening to followup (8 weeks)	Yes