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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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-ST or ST Elevation Acute Coronary Syndromes

Intervention: Ticagrelor (Drug); Clopidogrel (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Yundai Chen, Professor, Principal Investigator, Affiliation: The General Hospital of People's Liberation Army

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.

Clinical Details

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

Primary outcome: the Percentage Inhibition of the P2Y12 Receptor

Secondary outcome:

the Percentage Inhibition of the P2Y12 Receptor

the Percentage Inhibition of the P2Y12 Receptor

the Percentage Inhibition of the P2Y12 Receptor

the Percentage Inhibition of the P2Y12 Receptor

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Research Site, Beijing, China

Research Site, Shenyang, China

Research Site, Tianjin, China

Additional Information

D5130L00053_CSR_Synopsis

Starting date: May 2013
Last updated: April 28, 2015

Page last updated: August 23, 2015

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