Efficacy and Safety of Low-dose Ticagrelor

NCT ID: NCT03381742

Last Updated: 2019-09-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

3043 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-13

Study Completion Date

2019-02-13

Brief Summary

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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.

Detailed Description

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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. 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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ticagrelor 45mg bidpo.

To observe the efficacy and safety of ticagrelor 45mg bidpo. in patients with coronary artery disease.

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

ticagrelor 45 mg twice daily for 5 consecutive days at least.

ticagrelor 90mg qdpo.

To observe the efficacy and safety of ticagrelor 90mg qdpo. in patients with coronary artery disease.

Group Type EXPERIMENTAL

ticagrelor

Intervention Type DRUG

ticagrelor 90 mg once daily for 5 consecutive days at least.

ticagrelor 90mg bidpo.

To observe the efficacy and safety of ticagrelor 90mg bidpo. in patients with coronary artery disease.

Group Type ACTIVE_COMPARATOR

ticagrelor

Intervention Type DRUG

ticagrelor 90 mg twice daily for 5 consecutive days at least.

clopidogrel 75mg qdpo.

To observe the efficacy and safety of clopidogrel 75mg qdpo. in patients with coronary artery disease.

Group Type ACTIVE_COMPARATOR

clopidogrel

Intervention Type DRUG

clopidogrel 75 mg once daily for 5 consecutive days at least.

Interventions

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Ticagrelor

ticagrelor 45 mg twice daily for 5 consecutive days at least.

Intervention Type DRUG

ticagrelor

ticagrelor 90 mg once daily for 5 consecutive days at least.

Intervention Type DRUG

ticagrelor

ticagrelor 90 mg twice daily for 5 consecutive days at least.

Intervention Type DRUG

clopidogrel

clopidogrel 75 mg once daily for 5 consecutive days at least.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with coronary artery disease

Exclusion Criteria

* younger than 18 years of age;
* anti-platelet therapy with clopidogrel or ticagrelor for less than 5 days;
* previous or current treatment with any other potentially confounding drugs.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Anzhen Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role collaborator

The Central Hospital of Jia Mu Si City

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role collaborator

Weifang People's Hospital

OTHER

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Shengjing Hospital

OTHER

Sponsor Role collaborator

Shaanxi Provincial People's Hospital

OTHER

Sponsor Role collaborator

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, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Department, the First Affiliated Hospital of Harbin Medical University

Locations

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Thromboela-Stogram

Beijing, , China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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ACS-2

Identifier Type: -

Identifier Source: org_study_id

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