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NCT01864005 Clinical Trial

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

Non-ST or ST Elevation Acute Coronary Syndromes Clinical Trial

— HouYi  

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01864005
Other study ID # D5130L00053
Secondary ID
Status Completed
Phase Phase 4
First received May 24, 2013
Last updated April 28, 2015
Start date May 2013
Est. completion date March 2014

Study information
Verified date April 2015
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.
• 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.

Locations
Country Name City State
China Research Site Beijing
China Research Site Shenyang
China Research Site Tianjin

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary the Percentage Inhibition of the P2Y12 Receptor at 0.5 hour after first dose of study drug No
Secondary the Percentage Inhibition of the P2Y12 Receptor at 8 hours after first dose of study drug No
Secondary the Percentage Inhibition of the P2Y12 Receptor at 24 hours after first dose of study drug No
Secondary the Percentage Inhibition of the P2Y12 Receptor at 6 weeks after first dose of study drug No

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