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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01757262
First received: December 21, 2012
Last updated: May 10, 2013
Last verified: May 2013

December 21, 2012
May 10, 2013
January 2013
April 2013   (final data collection date for primary outcome measure)
  • Pharmacodynamics of Ticagrelor on P2Y12 receptor blockade measured by the VerifyNow P2Y12 assay[expressed as P2Y12 reaction units (PRU)] [ Time Frame: Day 1 pre-dose and at 0 (pre-dose), 1, 2, 8, 12 and 24 hours post morning dose on Day 5 ] [ Designated as safety issue: No ]
  • Pharmacodynamics of Clopidogrel P2Y12 receptor blockade measured by the VerifyNow P2Y12 assay[expressed as P2Y12 reaction units (PRU)] [ Time Frame: Day 1 pre-dose and at 0 (pre-dose), 1, 2, 8, 12 and 24 hours post morning dose on Day 5 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01757262 on ClinicalTrials.gov Archive Site
Safety profile in terms of adverse events, blood pressure, pulse, ECG (Electrocardiogram), physical examination, and safety laboratory variables [ Time Frame: From screening to followup (8 weeks) ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Clinical Study of Safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel in Vietnamese Patient
Safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel in Vietnamese Patients With Coronary Heart Disease: A Randomized, Open Label, Crossover Study

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

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Coronary Heart Disease
  • Drug: 90 mg Ticagrelor
    Morning and Evening dose for 5 days
  • Drug: 75mg Clopidogrel
    Morning dose for 5 days
  • Experimental: Ticagrelor
    90 mg Ticagrelor
    Intervention: Drug: 90 mg Ticagrelor
  • Active Comparator: Clopidogrel
    75mg Clopidogrel
    Intervention: Drug: 75mg Clopidogrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01757262
D5130C00078
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Nguyen Lan Viet, MD National Heart Institute, Bach Mai Hospital, Vietnam
Study Director: Judith Hsia, MD Astrazeneca, Wilmington, US
Study Chair: Miriana Kujacic, MD Astrazeneca, Molndal, Sweden
AstraZeneca
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP