A Phase IV Study of the Onset and Maintenance of the Antiplatelet Effect of Ticagrelor Compared With Clopidogrel in Chinese Patients With ACS (HouYi)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01864005
First received: May 24, 2013
Last updated: August 21, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to test the hypothesis that the onset of the antiplatelet effect of ticagrelor is more rapid and greater than clopidogrel in Chinese patients with ACS.


Condition Intervention Phase
Non-ST or ST Elevation Acute Coronary Syndromes
Drug: Ticagrelor
Drug: Clopidogrel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicentre, Open-label, Randomized, 6-week, Phase IV Study of the Onset and Maintenance of the Antiplatelet Effect of Ticagrelor Compared With Clopidogrel With Aspirin as Background Therapy in Chinese Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • P2Y12 reaction units (PRU) measured by Verify NowTM P2Y12 assay [ Time Frame: at 2 hours after first dose of study drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • P2Y12 reaction units (PRU) measured by Verify NowTM P2Y12 assay [ Time Frame: at 0.5, 8 and 24 hours and 6 weeks after first dose of study drug ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: May 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ticagrelor Drug: Ticagrelor
90mg tablets. loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. Duration of treatment: 6 weeks.
Active Comparator: clopidogrel Drug: Clopidogrel
75mg capsule. loading dose of 600mg clopidogrel capsules (eight 75mg capsules) taken orally, follow by 75mg of clopidogrel capsules orally od. Duration of treatment: 6 weeks.

  Eligibility

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

Inclusion Criteria:

  • 1. Provision of informed consent prior to any study specific procedures
  • 2. Female or male aged at least 18 years
  • 3. Females of child-bearing potential must have a negative urine pregnancy test at enrolment and be willing to use reliable contraception
  • 4. Index event of non-ST or ST segment elevation ACS.

Exclusion Criteria:

  • 1.Contraindication or other reason that clopidogrel or ticagrelor should not be administered (eg, hypersensitivity, active bleeding, moderate or severe liver disease, history of previous intracranial bleed, GI bleed within the past 6 months, major surgery within 30 days)
  • 2. Oral anticoagulation therapy or GP IIb/IIIa receptor antagonists therapy within 30 days prior to randomisation or cannot be stopped
  • 3. Ticagrelor or clopidogrel or other P2Y12 inhibitors within 14 days prior to randomisation
  • 4. Requires dialysis
  • 5. Nonselective non-steroidal anti-inflammatory drugs (NSAIDs) and prostacyclins (PGI2) therapy that cannot be stopped
  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: NCT01864005

Locations
China
Research Site
Beijing, China
Research Site
Shenyang, China
Research Site
Tianjin, China
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Yundai Chen, Professor The General Hospital of People's Liberation Army
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01864005     History of Changes
Other Study ID Numbers: D5130L00053
Study First Received: May 24, 2013
Last Updated: August 21, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by AstraZeneca:
Non-ST or ST Elevation Acute Coronary Syndromes, Ticagrelor, Clopidogrel, Antiplatelet Effect

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Disease
Pathologic Processes
Ticagrelor
Clopidogrel
Ticlopidine
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 19, 2014