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Antiplatelet Effects of Low-dose Ticagrelor and Standard-dose Clopidogrel in Chinese ACS Patients

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ClinicalTrials.gov Identifier: NCT03381742
Recruitment Status : Recruiting
First Posted : December 22, 2017
Last Update Posted : December 22, 2017
Sponsor:
Collaborators:
First Hospital of China Medical University
Jilin University
Information provided by (Responsible Party):
First Affiliated Hospital of Harbin Medical University

Brief Summary:
Guideline recommendations on the use of dual antiplatelet therapy have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for ACS patients. Recent study found that ticagrelor 90mg twice a day orally could significantly reduce the occurrence of clopidogrel resistance and adverse cardiovascular events. The previous studies have reported that half-dose ticagrelor had the similar inhibitory effect on platelet aggregation as the standard-dose ticagrelor, which was significantly stronger than that in the clopidogrel group. One-quarter standard-dose ticagrelor provided greater degree of platelet inhibition than standard dose clopidogrel in Chinese patients with stable CAD. But large-scale clinical trials are still needed to confirm the effects of low-dose ticagrelor on platelet function in Chinese patients with coronary heart disease.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: Ticagrelor Drug: ticagrelor Drug: clopidogrel Phase 2 Phase 3

Detailed Description:

Dual Antiplatelet Therapy (DAPT) with aspirin and P2Y12 receptor inhibitor remains a cornerstone in the secondary prevention of coronary artery disease (CAD). Clopidogrel is one of the most commonly used antithrombotic agent that inhibits the platelet P2Y(12) adenosine diphosphate (ADP) receptor.

Ticagrelor is an oral, reversibly-binding, direct-acting P2Y12 receptor antagonist used clinically for the prevention of atherothrombotic events in patients with acute coronary syndromes (ACS). Guideline recommendations on the use of dual antiplatelet therapy have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for ACS patients. Recent study found that ticagrelor 90mg twice a day orally could significantly reduce the occurrence of clopidogrel resistance and adverse cardiovascular events. The previous studies have reported that half-dose ticagrelor had the similar inhibitory effect on platelet aggregation as the standard-dose ticagrelor, which was significantly stronger than that in the clopidogrel group. One-quarter standard-dose ticagrelor provided greater degree of platelet inhibition than standard dose clopidogrel in Chinese patients with stable CAD. But large-scale clinical trials are still needed to confirm the effects of low-dose ticagrelor on platelet function in Chinese patients with coronary heart disease.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: "Real-World" Comparison of the Antiplatelet Effects of Low-dose Ticagrelor and Standard-dose Clopidogrel in Chinese ACS Patients
Actual Study Start Date : December 13, 2017
Estimated Primary Completion Date : December 13, 2019
Estimated Study Completion Date : February 13, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ticagrelor 45mg bidpo.
To observe ticagrelor 45mg bidpo. on platelet aggregation in patients with acute coronary syndrome.
Drug: Ticagrelor
half-dose ticagrelor treatment (90 mg loading dose, then 45 mg twice daily)for 5 days.

Experimental: ticagrelor 90mg qdpo.
To observe ticagrelor 90mg qdpo. on platelet aggregation in patients with acute coronary syndrome.
Drug: ticagrelor
half-dose ticagrelor treatment (90 mg loading dose, then 90 mg once daily) for 5 days.

Active Comparator: ticagrelor 90mg bidpo.
To observe standard-dose ticagrelor on platelet aggregation in patients with acute coronary syndrome.
Drug: ticagrelor
standard-dose ticagrelor treatment (180 mg loading dose, then 90 mg twice daily) for 5 days.

Active Comparator: clopidogrel 75mg qdpo.
To observe standard-dose clopidogrel on platelet aggregation in patients with acute coronary syndrome.
Drug: clopidogrel
standard-dose clopidogrel treatment (300 mg loading dose, then 75 mg once daily) for 5 days.




Primary Outcome Measures :
  1. The platelet aggregation rate [ Time Frame: up to 5 days ]
    thromboela-stogram


Secondary Outcome Measures :
  1. Side effects including bleeding,dyspnea and arrhythmia [ Time Frame: up to 5 days ]
  2. Adverse events including myocardial infarction, death, stroke, re-hospitalization for cardiovascular diseases and ischemia events [ Time Frame: up to 5 days ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with acute coronary syndrome

Exclusion Criteria:

  • taken adenosine diphosphate (ADP) receptor antagonists within 2 weeks
  • a history of bleeding tendency
  • aspirin, ticagrelor or clopidogrel allergies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03381742


Contacts
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Contact: Meijiao He, MM 86-451-85555673 hemeijiao99@sina.com

Locations
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China
Thromboela-Stogram Recruiting
Beijing, China, 100001
Contact: Liu Yang    86-010-801231171      
Sponsors and Collaborators
First Affiliated Hospital of Harbin Medical University
First Hospital of China Medical University
Jilin University
Investigators
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Principal Investigator: Yue Li, MD Cardiovascular Department, the First Affiliated Hospital of Harbin Medical University

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Responsible Party: First Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier: NCT03381742     History of Changes
Other Study ID Numbers: ACS-2
First Posted: December 22, 2017    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Myocardial Ischemia
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs