Clinical trial NCT03381742: Efficacy and Safety of Low-dose Ticagrelor
Official title: Efficacy and Safety of Different Ticagrelor Regimens Versus Clopidogrel in Patients With Coronary Artery Disease: a Retrospective Multicenter Study (SUPERIOR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Coronary Artery Disease
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
Collaborators: name: Beijing Anzhen Hospital
name: The First Affiliated Hospital of Dalian Medical University
name: The Central Hospital of Jia Mu Si City
name: First Affiliated Hospital of Kunming Medical University
name: RenJi Hospital
name: Tianjin Medical University General Hospital
name: Weifang People's Hospital
name: Wuhan Union Hospital, China
name: Shengjing Hospital
name: Shaanxi Provincial People's Hospital
First posted: 2017-12-22
Enrollment: 3043
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: ADP-induced Inhibition of Platelet Aggregation
timeFrame: up to 5 days
measure: Number of Participants With Bleeding (Major or Minor Bleeding)
timeFrame: up to 5 days
Secondary outcomes:
measure: ADP-induced Platelet-fibrin Clot Strength (MA)
timeFrame: up to 5 days
measure: Number of Participants With High On-Treatment Platelet Reactivity (HTPR)
timeFrame: up to 5 days
measure: Number of Participants With Cardiovascular Event (Cardiovascular Death, New-onset Myocardial Infarction, or Stroke)
timeFrame: up to 5 days
measure: Number of Participants With New-onset Dyspnea
timeFrame: up to 5 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Thromboela-Stogram
Study officials:
affiliation: Cardiovascular Department, the First Affiliated Hospital of Harbin Medical University
name: Yue Li, MD
role: PRINCIPAL_INVESTIGATOR
References: