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OpenTrials
Completed

NCT Number: NCT01864005

A Phase IV Study of the Onset and Maintenance of the Antiplatelet Effect of Ticagrelor Compared With Clopidogrel in Chinese Patients With 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.

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Key information

Conditions

Non-ST or ST Elevation Acute Coronary Syndromes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ticagrelor

Drug

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.

clopidogrel

Drug

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Acronym: HouYi

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 29, 2013
Registry last updated
May 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.