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

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.

Study Overview

• Status: Completed
• Conditions: Non-ST or ST Elevation Acute Coronary Syndromes
• Intervention / Treatment: Drug: Ticagrelor; Drug: Clopidogrel

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Research Site
  • Shenyang, China
    • Research Site
  • Tianjin, China
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
the Percentage Inhibition of the P2Y12 Receptor	at 0.5 hour after first dose of study drug
the Percentage Inhibition of the P2Y12 Receptor	at 8 hours after first dose of study drug
the Percentage Inhibition of the P2Y12 Receptor	at 24 hours after first dose of study drug
the Percentage Inhibition of the P2Y12 Receptor	at 6 weeks after first dose of study drug

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Yundai Chen, Professor, The General Hospital of People's Liberation Army

Publications and helpful links

Helpful Links

• D5130L00053_CSR_Synopsis

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: May 24, 2013
• First Submitted That Met QC Criteria: May 24, 2013
• First Posted (Estimate): May 29, 2013

Study Record Updates

• Last Update Posted (Estimate): May 15, 2015
• Last Update Submitted That Met QC Criteria: April 28, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Non-ST or ST Elevation Acute Coronary Syndromes, Ticagrelor, Clopidogrel, Antiplatelet Effect
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Ticagrelor; Clopidogrel
• Other Study ID Numbers: D5130L00053