Completed

Antithrombotic Effects Comparison: Ticagrelor vs Clopidogrel in Type 2 Diabetic Patients

Study Aim

This study aims to compare the antithrombotic effects of Ticagrelor and Clopidogrel in patients with Type 2 Diabetes, specifically focusing on the formation of blood clots in an ex vivo model of thrombosis.

What is being tested

Ticagrelor + Aspirin

+ Clopidogrel + Aspirin

Drug

Who is being recruted

Arterial Occlusive Diseases+12

+ Arteriosclerosis

+ Cardiovascular Diseases

From 18 to 75 Years

+19 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 4

Interventional

Study Start: July 2013

See protocol details

Summary

Principal SponsorJuan J Badimon

Last updated: December 8, 2017

Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2013

Actual date on which the first participant was enrolled.

The rising prevalence of diabetes mellitus and its associated cardiovascular complications present a major burden to healthcare providers worldwide. Cardiovascular mortality is much higher among subjects with Type 2 Diabetes Mellitus (T2DM). Increased platelet reactivity is considered a potential link between the two diseases. Thus, given the higher blood thrombogenicity of T2DM with CAD, the availability of more potent antiplatelet drugs should be associated with improvements in the prevention of cardiovascular events in the diabetic populations. Ticagrelor has been shown to possess a faster onset of action and more potency than clopidogrel. Furthermore, the PLATO has shown that these characteristics results in a significant reduction in Cardiovascular events and even death as compared with Clopidogrel. We plan to compare the antithrombotic activity of ticagrelor versus clopidogrel in T2DM patients using a cross-over study design. Each participant will be randomly assigned to receive ticagrelor/clopidogrel + aspirin as a loading dose followed by 5-7 days of daily maintenance dosing. After a washout period of 1-2 weeks, each participant will receive the second treatment (clopidogrel/ticagrelor + aspirin) again as a loading dose followed by 5-7 days of daily dosing. Platelet function will be tested at pre-treatment baseline, two post-dose time-points on the day of loading dose, and one time-point after the last maintenance dose on day 5-7. Platelet testing will be carried out using the following methodologies: Badimon Perfusion Chamber: an ex-vivo model of thrombosis that has been extensively utilized for evaluation of antithrombotic or prothrombotic effects under various pathological states. The model involves native blood perfusing over a thrombogenic substrate, triggering thrombus formation that can be measured by planimetry. Platelet Aggregation - Multiplate Analyzer. Platelet Aggregation - VerifyNow P2Y12 assay. Vasodilator-Stimulated Phosphoprotein (VASP).

NCT01823510

Principal SponsorJuan J Badimon

Last updated: December 8, 2017

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesCoronary DiseaseEndocrine System DiseasesHeart DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesEmbolism and ThrombosisMyocardial IschemiaGlucose Metabolism DisordersCoronary Artery DiseaseDiabetes MellitusThrombosis

Criteria

4 inclusion criteria required to participate

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

Diagnosed with type-2 diabetes being treated with oral or parenteral hypoglycemic therapy or both

For women of child-bearing potential only test negative for pregnancy at the time of enrollment

Have not had thienopyridine therapy for at least 30 days before the study

15 exclusion criteria prevent from participating

Are receiving daily treatment with non-steroidal anti-inflammatory drugs (NSAIDS) that cannot be discontinued

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

Have a concomitant medical illness that in the opinion of the investigator may interfere with or prevent completion in this study

Have a defined need for thienopyridine therapy

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Loading-dose plus daily-dosing for 5-7 days.

Group II

Active Comparator

Loading-dose plus daily-dosing for 5-7 days.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Icahn School of Medicine at Mount Sinai

New York, United StatesOpen Icahn School of Medicine at Mount Sinai in Google Maps

CompletedOne Study Center