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

NCT01864005 | Completed Phase 4 Results

• 1 other identifier: D5130L00053
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Non-ST or ST Elevation Acute Coronary Syndromes

Keywords

Non-ST or ST Elevation Acute Coronary Syndromes, Ticagrelor, Clopidogrel, Antiplatelet Effect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Ticagrelor

EXPERIMENTAL

Drug: Ticagrelor

clopidogrel

ACTIVE COMPARATOR

Drug: Clopidogrel

Interventions

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.

Ticagrelor

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.

clopidogrel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Provision of informed consent prior to any study specific procedures
• \. Female or male aged at least 18 years
• \. Females of child-bearing potential must have a negative urine pregnancy test at enrolment and be willing to use reliable contraception
• \. Index event of non-ST or ST segment elevation ACS.

You may not qualify if:

• 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)
• \. Oral anticoagulation therapy or GP IIb/IIIa receptor antagonists therapy within 30 days prior to randomisation or cannot be stopped
• \. Ticagrelor or clopidogrel or other P2Y12 inhibitors within 14 days prior to randomisation
• \. Requires dialysis
• \. Nonselective non-steroidal anti-inflammatory drugs (NSAIDs) and prostacyclins (PGI2) therapy that cannot be stopped

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (3)

Research Site

Beijing, China

Location

Research Site

Shenyang, China

Location

Research Site

Tianjin, China

Location

Related Links

• D5130L00053\_CSR\_Synopsis

MeSH Terms

Interventions

Ticagrelor; Clopidogrel

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

(1) Sample size was relatively small. (2) Study duration with 6 weeks seemed limited. (3) Sampling time-points seemed relatively scarce, such as missing the time point for 1-hour and 4-hour after loading dose.

Results Point of Contact

• Title: Judith Hsia
• Organization: Astrazeneca

judithhsia@astrazeneca.com

1-301-398-0102

Study Officials

• Yundai Chen, Professor

  The General Hospital of People's Liberation Army

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: May 29, 2013
• Study Start: May 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 15, 2015
• Results First Posted: March 2, 2015

Record last verified: 2015-04

Locations

CN (3)