A Clinical Study of Safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel in Vietnamese Patient

NCT01757262 | Withdrawn Phase 3

• 1 other identifier: D5130C00078
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study in Vietnamese Patients with Coronary Heart Disease to investigate safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel

Conditions

Coronary Heart Disease

Keywords

Coronary Heart Disease

Outcome Measures

Primary Outcomes (2)

• Pharmacodynamics of Ticagrelor on P2Y12 receptor blockade measured by the VerifyNow P2Y12 assay[expressed as P2Y12 reaction units (PRU)]

  Day 1 pre-dose and at 0 (pre-dose), 1, 2, 8, 12 and 24 hours post morning dose on Day 5

• Pharmacodynamics of Clopidogrel P2Y12 receptor blockade measured by the VerifyNow P2Y12 assay[expressed as P2Y12 reaction units (PRU)]

  Day 1 pre-dose and at 0 (pre-dose), 1, 2, 8, 12 and 24 hours post morning dose on Day 5

Secondary Outcomes (1)

• Safety profile in terms of adverse events, blood pressure, pulse, ECG (Electrocardiogram), physical examination, and safety laboratory variables

  From screening to followup (8 weeks)

Study Arms (2)

Ticagrelor

EXPERIMENTAL

90 mg Ticagrelor

Drug: 90 mg Ticagrelor

Clopidogrel

ACTIVE COMPARATOR

75mg Clopidogrel

Drug: 75mg Clopidogrel

Interventions

90 mg Ticagrelor DRUG

Morning and Evening dose for 5 days

Ticagrelor

75mg Clopidogrel DRUG

Morning dose for 5 days

Clopidogrel

Eligibility Criteria

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

You may qualify if:

• Male or female Vietnamese patients (as confirmed by the Principal Investigator) aged \>18 years with suitable veins for cannulations or repeated venipunctures and stable coronary heart disease
• Stable use of aspirin 75 to 100 mg daily for at least the preceding 2 weeks and which will be continued throughout the study period
• Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive
• Women must have a negative urine pregnancy test at Visit 1

You may not qualify if:

• History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study
• Unstable angina or any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IP
• Patients who had acute coronary syndrome or stent placed within 12 months of screening
• Planned arterial revascularization
• Current use of ADP receptor blockers (eg, clopidogrel, ticlopidine, prasugrel), dipyridamole or cilostazol

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Coronary Disease

Interventions

Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

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

Study Officials

• Nguyen Lan Viet, MD

  National Heart Institute, Bach Mai Hospital, Vietnam

  PRINCIPAL INVESTIGATOR

• Judith Hsia, MD

  Astrazeneca, Wilmington, US

  STUDY DIRECTOR

• Miriana Kujacic, MD

  Astrazeneca, Molndal, Sweden

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2012
• First Posted: December 28, 2012
• Study Start: January 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 13, 2013

Record last verified: 2013-05