Efficacy and Safety of Low-dose Ticagrelor

Harbin Medical University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Coronary Artery Disease

Treatments: Drug: ticagrelor; Drug: clopidogrel; Drug: Ticagrelor

Study type: Interventional

Funder types: Other

Identifiers

NCT03381742

ACS-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,043 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,043 participants in 4 patient groups

ticagrelor 45mg bidpo.

Experimental group

Description:

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

Treatment:

Drug: Ticagrelor

ticagrelor 90mg qdpo.

Experimental group

Description:

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

Treatment:

Drug: ticagrelor

Drug: ticagrelor

ticagrelor 90mg bidpo.

Active Comparator group

Description:

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

Treatment:

Drug: ticagrelor

Drug: ticagrelor

clopidogrel 75mg qdpo.

Active Comparator group

Description:

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

Treatment:

Drug: clopidogrel