- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03381742
Efficacy and Safety of Low-dose Ticagrelor
Efficacy and Safety of Different Ticagrelor Regimens Versus Clopidogrel in Patients With Coronary Artery Disease: a Retrospective Multicenter Study (SUPERIOR)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Beijing, China, 100001
- Thromboela-Stogram
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ticagrelor 45mg bidpo.
To observe the efficacy and safety of ticagrelor 45mg bidpo. in patients with coronary artery disease.
|
ticagrelor 45 mg twice daily for 5 consecutive days at least.
|
Experimental: ticagrelor 90mg qdpo.
To observe the efficacy and safety of ticagrelor 90mg qdpo. in patients with coronary artery disease.
|
ticagrelor 90 mg once daily for 5 consecutive days at least.
ticagrelor 90 mg twice daily for 5 consecutive days at least.
|
Active Comparator: ticagrelor 90mg bidpo.
To observe the efficacy and safety of ticagrelor 90mg bidpo. in patients with coronary artery disease.
|
ticagrelor 90 mg once daily for 5 consecutive days at least.
ticagrelor 90 mg twice daily for 5 consecutive days at least.
|
Active Comparator: clopidogrel 75mg qdpo.
To observe the efficacy and safety of clopidogrel 75mg qdpo. in patients with coronary artery disease.
|
clopidogrel 75 mg once daily for 5 consecutive days at least.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ADP-induced Inhibition of Platelet Aggregation
Time Frame: up to 5 days
|
The venous blood samples for platelet function test were drawn after an overnight fast, at 12 hours post-last study-drug dose for subjects receiving twice-daily administrations, and at 24 hours post-last study-drug dose for subjects treated with once-daily regimens.
The blood was collected in an evacuated vacuum tube containing 3.2% trisodium citrate and lithium heparin.
Then the samples were processed within two hours of blood draw according to standard operating procedure.
The physical properties of samples were analyzed using Thromboelastography (TEG) Hemostasis Analyzer (CFMS LEPU-8800, Lepu Medical Technology Co., Ltd, Beijing, China) and automated analytical software.
TEG test used four channels to detect the effects of anti-platelet therapy via the arachidonic acid (AA) and ADP pathways.
TEG test results were expressed in terms of ADP-induced inhibition of platelet aggregation (IPA, range 0% - 100%), with higher values indicating greater platelet inhibition.
|
up to 5 days
|
Number of Participants With Bleeding (Major or Minor Bleeding)
Time Frame: up to 5 days
|
Major bleeding was defined as type ≥ 3 and minor bleeding as types 1 and 2, in accordance to the Bleeding Academic Research Consortium classification.
(Mehran R et al.
Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium.
Circulation.
2011 Jun 14;123(23):2736-47.
doi: 10.1161/CIRCULATIONAHA.110.009449.)
|
up to 5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ADP-induced Platelet-fibrin Clot Strength (MA)
Time Frame: up to 5 days
|
The physical properties of samples were analyzed using Thromboelastography (TEG) Hemostasis Analyzer (CFMS LEPU-8800, Lepu Medical Technology Co., Ltd, Beijing, China) and automated analytical software.
TEG test used four channels to detect the effects of anti-platelet therapy via the arachidonic acid (AA) and ADP pathways.
TEG test results were expressed in terms of ADP-induced platelet-fibrin clot strength (MA).
A MA>47mm was shown to have a high predictive value for 3-year post-PCI ischemic events during dual antiplatelet therapy.
Moreover, ROC curve and quartile analysis suggested MA<31 mm as a predictive value for post-PCI bleeding events (J Am Coll Cardiol.
2013;62(24):2261-73. doi: 10.1016/j.jacc.2013.07.101.).
|
up to 5 days
|
Number of Participants With High On-Treatment Platelet Reactivity (HTPR)
Time Frame: up to 5 days
|
HTPR was defined as IPA ≤ 30% and MA ≥ 47 mm.
|
up to 5 days
|
Number of Participants With Cardiovascular Event (Cardiovascular Death, New-onset Myocardial Infarction, or Stroke)
Time Frame: up to 5 days
|
Cardiovascular death was defined as sudden cardiac death, fatal myocardial infarction, death due to heart failure, or death due to other cardiovascular causes.
Stroke was defined as the focal loss of neurologic function caused by an ischemic or a hemorrhagic event with residual symptoms lasting at least 24 hours or eventually leading to death.
|
up to 5 days
|
Number of Participants With New-onset Dyspnea
Time Frame: up to 5 days
|
New-onset dyspnea in patients without previous history of dyspnea
|
up to 5 days
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yue Li, MD, Cardiovascular Department, the First Affiliated Hospital of Harbin Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Platelet Aggregation Inhibitors
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Ticagrelor
- Clopidogrel
Other Study ID Numbers
- ACS-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Disease
-
Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
-
China National Center for Cardiovascular DiseasesRecruitingLeft Main Coronary Artery DiseaseChina
Clinical Trials on Ticagrelor
-
Federico II UniversityAdvicePharma GroupCompletedMyocardial Infarction | Coronary Artery Disease | Acute Coronary Syndrome | STEMI | NSTEMIItaly
-
Collegium Medicum w BydgoszczyCompleted
-
University of FloridaCompleted
-
AstraZenecaParexelCompletedSickle Cell DiseaseGermany
-
University of FloridaThe Medicines CompanyCompletedCoronary Artery DiseaseUnited States
-
University of FloridaAstraZenecaCompleted
-
Centro Hospitalario La ConcepcionRecruiting
-
Sheba Medical CenterCompletedST Elevation Myocardial Infarction | Acute Coronary SyndromesIsrael
-
David AntoniucciAstraZeneca; A.R. CARD Onlus FoundationCompletedAcute Coronary Syndrome | Adverse Reaction to Antiplatelet AgentItaly, Greece
-
AstraZenecaCompletedMyocardial Infarction | Stroke | Atherothrombosis | Cardiovascular DeathSweden, United States, Australia, Brazil, Bulgaria, Czech Republic, France, Italy, Korea, Republic of, Peru, Poland, Russian Federation, South Africa, Spain, Turkey, United Kingdom, Germany, Philippines, China, Hungary, Romania, U... and more