Ticagrelor Versus Clopidogrel in Type 2 Diabetic Patients
Comparative Study of the Antithrombotic Effects of Ticagrelor and Clopidogrel in Type 2 Diabetic Patients
1 other identifier
interventional
20
1 country
1
Brief Summary
The purpose of this study is to determine whether treatment with ticagrelor + aspirin is more effective than treatment with clopidogrel + aspirin in patients with type-2 diabetes. Both treatments will be given (separately) to all subjects as a one-time loading dose (i.e. higher than a normal daily dose), followed by daily dose for the next 5 to 7 days. Effectiveness of treatment will be measured with specialized blood tests before the loading dose, at two time-points after the loading dose, and once after the last daily dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2013
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2013
CompletedFirst Posted
Study publicly available on registry
April 4, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2016
CompletedResults Posted
Study results publicly available
September 1, 2017
CompletedDecember 8, 2017
December 1, 2017
2.9 years
March 29, 2013
June 19, 2017
December 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Thrombus Formation
Thrombus formation in Badimon Perfusion Chamber high-shear) (ex vivo model of thrombosis).
up to 7 days
Secondary Outcomes (3)
Platelet Reactivity
up to 7 days
P2Y12 Reaction Unit (PRU)
up to 7 days
Platelet Reactivity Index (PRI)
up to 7 days
Study Arms (2)
Ticagrelor + Aspirin
EXPERIMENTALLoading-dose plus daily-dosing for 5-7 days.
Clopidogrel + Aspirin
ACTIVE COMPARATORLoading-dose plus daily-dosing for 5-7 days.
Interventions
Single loading doses of Ticagrelor (180 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (ticagrelor 90 mg twice daily + ASA 81 mg once daily).
Single loading doses of Clopidogrel (600 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (clopidogrel 75 mg + ASA 81 mg once daily).
Eligibility Criteria
You may qualify if:
- Diagnosed with type-2 diabetes being treated with oral or parenteral hypoglycemic therapy or both.
- Have not had thienopyridine therapy for at least 30 days before the study.
- Are of legal age (at least 18 years of age but less than 75 years of age) and competent mental condition to provide written informed consent.
- For women of child-bearing potential only test negative for pregnancy at the time of enrollment.
You may not qualify if:
- Have a defined need for thienopyridine therapy.
- Subjects within ≤30 days of coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI).
- Known glycosylated hemoglobin (HbA1c) ≥10 mg/dL within last 3 months prior to study entry.
- Have received fibrinolytic therapy \<48 hours prior to randomization.
- Have active internal bleeding or history of bleeding diathesis.
- Have clinical findings that are, in the judgment of the investigator, associated with an increased risk of bleeding.
- Have history of ischemic or hemorrhagic stroke, transient ischemic attack (TIA) or intracranial neoplasm, arteriovenous malformation, or aneurysm.
- Have an International Normalized Ratio (INR) known to be \>1.5 within 1 week of study entry.
- Have a known platelet count of \<100,000/mm3 within 1 week of study entry.
- Have known anemia (hemoglobin \[Hgb\] \<10 gm/dL) within 1 week of study entry.
- Are receiving or will receive oral anticoagulation or other antiplatelet therapy (other than ASA) that cannot be safely discontinued for the duration of the trial.
- Are receiving daily treatment with non-steroidal anti-inflammatory drugs (NSAIDS) that cannot be discontinued.
- Have a concomitant medical illness that in the opinion of the investigator may interfere with or prevent completion in this study.
- Have known severe hepatic dysfunction (e.g., cirrhosis or portal hypertension).
- Have a history of intolerance or allergy to ASA or approved thienopyridines (ticlopidine or clopidogrel).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Juan J Badimonlead
- AstraZenecacollaborator
Study Sites (1)
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Related Publications (1)
Zafar MU, Baber U, Smith DA, Sartori S, Contreras J, Rey-Mendoza J, Linares-Koloffon CA, Escolar G, Mehran R, Fuster V, Badimon JJ. Antithrombotic potency of ticagrelor versus clopidogrel in type-2 diabetic patients with cardiovascular disease. Thromb Haemost. 2017 Oct 5;117(10):1981-1988. doi: 10.1160/TH17-04-0277. Epub 2017 Aug 24.
PMID: 28837213DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Juan Badimon
- Organization
- Icahn School of Medicine at Mount Sinai
Study Officials
- PRINCIPAL INVESTIGATOR
Juan J Badimon, PhD
Icahn School of Medicine at Mount Sinai
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 29, 2013
First Posted
April 4, 2013
Study Start
July 1, 2013
Primary Completion
May 10, 2016
Study Completion
May 10, 2016
Last Updated
December 8, 2017
Results First Posted
September 1, 2017
Record last verified: 2017-12