Low-dose Ticagrelor in Chinese ACS Patients Undergoing PCI

NCT ID: NCT03381755

Last Updated: 2018-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-12-14

Brief Summary

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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. 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 the effectiveness and safety of low-dose ticagrelor remain yet not very clearly in Chinese patients with acute coronary syndrome undergoing percutaneous coronary intervention.

Detailed Description

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Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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half-dose ticagrelor

Group Type EXPERIMENTAL

half-dose ticagrelor

Intervention Type DRUG

To observe the effectiveness and safety of ticagrelor 45mg bidpo. in Chinese ACS patients undergoing PCI.

standard-dose ticagrelor

Group Type ACTIVE_COMPARATOR

standard-dose ticagrelor

Intervention Type DRUG

To observe the effectiveness and safety of ticagrelor 90mg bidpo. in Chinese ACS patients undergoing PCI.

Interventions

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half-dose ticagrelor

To observe the effectiveness and safety of ticagrelor 45mg bidpo. in Chinese ACS patients undergoing PCI.

Intervention Type DRUG

standard-dose ticagrelor

To observe the effectiveness and safety of ticagrelor 90mg bidpo. in Chinese ACS patients undergoing PCI.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* After half-dose ticagrelor (loading dose 90mg, and then 45mg bidpo.) treatment for 3 days, the platelet aggregation is effectively inhibited by light transmission aggregometry method and thromboela-stogram.
* planned to undergo PCI recently
* planned to DAPT for 1 year after PCI

Exclusion Criteria

* taken adenosine diphosphate (ADP) receptor antagonists within 2 weeks
* Platelet count \<100g/L;
* A history of bleeding tendency;
* Aspirin, ticagrelor or clopidogrel allergies;
* Severe liver injury.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yue Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Department, the First Affiliated Hospital of Harbin Medical University

Locations

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Thromboela-Stogram

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guangzhong Liu, PhD

Role: CONTACT

86-451-85555673

Facility Contacts

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Liu Yang, MM

Role: primary

86-010-801231171

Other Identifiers

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ACS-3

Identifier Type: -

Identifier Source: org_study_id

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