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Arachidonic Acid-induced Platelet Aggregation Rate in Patients With Stable CAD Treated With Ticagrelor Monotherapy

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Peking University First Hospital
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Yong Huo, Peking University First Hospital
ClinicalTrials.gov Identifier:
NCT02219412
First received: July 24, 2014
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

This study was a feasibility trial that was designed to provide preliminary observations and generate hypotheses for future studies. The aim of the study is to estimate the difference of arachidonic acid induced platelet aggregation rate between ticagrelor mono-therapy and aspirin/ticagrelor dual-therapy after 14 days of treatment in patients with stable coronary artery disease. The potential hypothesis is that the arachidonic acid (AA) induced platelet aggregation rate after 2 weeks of ticagrelor mono-therapy is comparable to that of aspirin/ticagrelor dual-therapy.


Condition Intervention Phase
Coronary Heart Disease
Drug: ticagrelor
Drug: Aspirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Two Arms, Randomized Controlled Pilot Study Comparing the Arachidonic Acid-induced Platelet Aggregation Rate in Patients With Stable Coronary Artery Disease Treated With Ticagrelor Monotherapy or Ticagrelor and Asprin

Resource links provided by NLM:


Further study details as provided by Peking University First Hospital:

Primary Outcome Measures:
  • The rate of AA induced platelet aggregation [ Time Frame: Day 14 after randomization ] [ Designated as safety issue: No ]
    The rate of AA induced platelet aggregation will be measured at day 14 after randomization.


Secondary Outcome Measures:
  • The rate of ADP induced platelet aggregation [ Time Frame: Day 7 and day 14 after randomization ] [ Designated as safety issue: No ]
    The rate of ADP induced platelet aggregation will be measured at day 7 and day 14 after randomization.

  • The rate of collagen induced platelet aggregation [ Time Frame: Day 7 and day 14 after randomization ] [ Designated as safety issue: No ]
    The rate of d collagen induced platelet aggregation will be measured at day 7 and day 14 after randomization.

  • The serum concentration of Thromboxane B2 [ Time Frame: Day 7 and day 14 after randomization ] [ Designated as safety issue: No ]
    The serum concentration of Thromboxane B2 will be measured at day7 and day 14 after randomization

  • The rate of AA induced platelet aggregation [ Time Frame: Day 7 after randomization ] [ Designated as safety issue: No ]
    The rate of collagen induced platelet aggregation will be measured on Day 7 after randomization


Estimated Enrollment: 60
Study Start Date: August 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ticagrelor mono-therapy
Take ticagrelor 90 mg Bid for 2 weeks.
Drug: ticagrelor
90 mg bid for 2 weeks
Other Name: Brilinta
Active Comparator: aspirin/ticagrelor dual-therapy
Take ticagrelor 90mg Bid plus Aspirin 100mg Qd and treated for 2 weeks.
Drug: ticagrelor
90 mg bid for 2 weeks
Other Name: Brilinta
Drug: Aspirin
100mg Qd for 2 weeks.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures.
  • Aged >18 years.
  • Documented stable coronary artery disease.
  • Currently receiving dual-antiplatelet therapy with aspirin 100mg/d and clopidogrel 75mg/d.

Exclusion Criteria:

  • History of acute coronary syndrome within 12 months of screening.
  • History of percutaneous coronary intervention within 12 months of screening.
  • Any indication (eg, atrial fibrillation,prosthetic heart valve, or coronary stent) for antithrombotic therapy(eg, warfarin, clopidogrel, or aspirin dose other than 75 to 100 mg/during the study period).
  • AA induced platelet aggregation rate >20% on aspirin+clopidogrel measured by light transmission platelet aggregation test with the past 3 months.
  • Congestive heart failure or left ventricular ejection fraction <35%.
  • Forced expiratory volume in the first second forced vital capacity below the lower limits of normal.
  • Bleeding diathesis or severe pulmonary disease.
  • Active pathological bleeding.
  • History of intracranial hemorrhage.
  • Hypersensitivity to ticagrelor or any of the excipients.
  • Severe hepatic impairment.
  • Pregnancy.
  • Current smoking.
  • Platelet count <100 000/mm3 or hemoglobin <10 g/dL.
  • HemoglobinA1c >10%.
  • History of drug addiction or alcohol abuse in the past 2 years.
  • Need for nonsteroidal anti-inflammatory drug.
  • Creatinine clearance<30 mL/min.
  • Concomitant therapy with moderate or strong cytochrome P450 3A inhibitors, substrates, or strong cytochrome P450 3A inducers.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02219412

Contacts
Contact: Huo Yong, MD 86 (10)83572283 huoyong@263.net.cn

Locations
China
Peking University First Hospital Not yet recruiting
Beijing, China, 100034
Contact: Huo Yong, MD    86 (10)6655-1122 ext 2283    huoyong@263.net.cn   
Principal Investigator: Huo Yong, MD         
Sub-Investigator: Jiang Jie, MD         
Sponsors and Collaborators
Yong Huo
AstraZeneca
Investigators
Study Chair: Huo Yong, MD Peking University First Hospital
  More Information

No publications provided

Responsible Party: Yong Huo, The director of the Department of Cardiology and heart center of Peking University First Hospital, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT02219412     History of Changes
Other Study ID Numbers: ISSBRIL0235
Study First Received: July 24, 2014
Last Updated: August 15, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Peking University First Hospital:
ticagrelor
platelet aggregation rate
ADP antagonist
antiplatelet therapy

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Vascular Diseases
Aspirin
Ticagrelor
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents

ClinicalTrials.gov processed this record on November 20, 2014