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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01864005
First received: May 24, 2013
Last updated: February 26, 2014
Last verified: February 2014

May 24, 2013
February 26, 2014
May 2013
January 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01864005 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Phase IV Study of the Onset and Maintenance of the Antiplatelet Effect of Ticagrelor Compared With Clopidogrel in Chinese Patients With ACS
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)

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-ST or ST Elevation Acute Coronary Syndromes
  • 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.
  • 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.
  • Experimental: Ticagrelor
    Intervention: Drug: Ticagrelor
  • Active Comparator: clopidogrel
    Intervention: Drug: Clopidogrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
January 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01864005
D5130L00053
No
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Yundai Chen, Professor The General Hospital of People's Liberation Army
AstraZeneca
February 2014

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