A Clinical Study of Safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel in Vietnamese Patient - Full Text View

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:

MedlinePlus related topics: Coronary Artery Disease Heart Diseases

Drug Information available for: Clopidogrel bisulfate Ticagrelor

U.S. FDA Resources

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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:


Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases Clopidogrel Ticlopidine Ticagrelor Platelet Aggregation Inhibitors	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 Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 27, 2016