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This study has been withdrawn prior to enrollment.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
  Purpose

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


Condition Intervention Phase
Coronary Heart Disease
Drug: 90 mg Ticagrelor
Drug: 75mg Clopidogrel
Phase 3

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: January 2013
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ticagrelor
90 mg Ticagrelor
Drug: 90 mg Ticagrelor
Morning and Evening dose for 5 days
Active Comparator: Clopidogrel
75mg Clopidogrel
Drug: 75mg Clopidogrel
Morning dose for 5 days

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01757262

Sponsors and Collaborators
AstraZeneca
Investigators
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
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01757262     History of Changes
Other Study ID Numbers: D5130C00078
Study First Received: December 21, 2012
Last Updated: May 10, 2013
Health Authority: Vietnam: Ministry of Health - Vietnam

Keywords provided by AstraZeneca:
Coronary Heart Disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Ticlopidine
Ticagrelor
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 16, 2014