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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01864005
Recruitment Status : Completed
First Posted : May 29, 2013
Results First Posted : March 2, 2015
Last Update Posted : May 15, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Non-ST or ST Elevation Acute Coronary Syndromes Drug: Ticagrelor Drug: Clopidogrel Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : May 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. the Percentage Inhibition of the P2Y12 Receptor [ Time Frame: at 2 hours after first dose of study drug ]
    Note: the primary endpoint was changed per the statistical analysis plan prior database lock.


Secondary Outcome Measures :
  1. the Percentage Inhibition of the P2Y12 Receptor [ Time Frame: at 0.5 hour after first dose of study drug ]
  2. the Percentage Inhibition of the P2Y12 Receptor [ Time Frame: at 8 hours after first dose of study drug ]
  3. the Percentage Inhibition of the P2Y12 Receptor [ Time Frame: at 24 hours after first dose of study drug ]
  4. the Percentage Inhibition of the P2Y12 Receptor [ Time Frame: at 6 weeks after first dose of study drug ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864005


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

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01864005    
Other Study ID Numbers: D5130L00053
First Posted: May 29, 2013    Key Record Dates
Results First Posted: March 2, 2015
Last Update Posted: May 15, 2015
Last Verified: April 2015
Keywords provided by AstraZeneca:
Non-ST or ST Elevation Acute Coronary Syndromes, Ticagrelor, Clopidogrel, Antiplatelet Effect
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
 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