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Type-2 Diabetes MellitusPhase 4NCT01823510

Ticagrelor Versus Clopidogrel in Type 2 Diabetic Patients

A Phase 4 study testing Ticagrelor + Aspirin and Clopidogrel + Aspirin in people with Type-2 Diabetes Mellitus and Coronary Artery Disease, run by Juan J Badimon at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Ticagrelor + Aspirin and Clopidogrel + Aspirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Jul 2013to 10 May 2016
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

Official title: Comparative Study of the Antithrombotic Effects of Ticagrelor and Clopidogrel in Type 2 Diabetic Patients

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.

Read the detailed description

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:

  1. 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.
  2. Platelet Aggregation - Multiplate Analyzer.
  3. Platelet Aggregation - VerifyNow P2Y12 assay.
  4. Vasodilator-Stimulated Phosphoprotein (VASP).
Being tested
Ticagrelor + Aspirin, Clopidogrel + Aspirin
Keywords
Antiplatelet, Ticagrelor, Clopidogrel, Thrombosis, Diabetes, Coronary Artery Disease
Medical subject headings
Coronary Artery Disease, Thrombosis, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ticagrelor + AspirinDrug

    Also called Brilinta (ticagrelor), Aspirin (ASA)

    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).

  • Clopidogrel + AspirinDrug

    Also called Plavix (clopidogrel), Aspirin (ASA)

    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).

Study groups in NCT01823510
Study groupRoleWhat they receive
Ticagrelor + AspirinExperimentalLoading-dose plus daily-dosing for 5-7 days.
Receives: Drug: Ticagrelor + Aspirin
Clopidogrel + AspirinActive comparatorLoading-dose plus daily-dosing for 5-7 days.
Receives: Drug: Clopidogrel + Aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Thrombus Formation

    Thrombus formation in Badimon Perfusion Chamber high-shear) (ex vivo model of thrombosis).

    Measured: up to 7 days

Secondary outcomes (3)

  1. Platelet Reactivity

    Platelet reactivity by Multiplate Analyzer

    Measured: up to 7 days

  2. P2Y12 Reaction Unit (PRU)

    Platelet reactivity by measuring P2Y12 Reaction Unit using Accumetrics VerifyNow

    Measured: up to 7 days

  3. Platelet Reactivity Index (PRI)

    Platelet reactivity index by Vasodilator-Stimulated Phosphoprotein phosphorylation (VASP) assay.

    Measured: up to 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2013 (estimated)
  2. Study startJul 2013
  3. Primary completion10 May 2016
  4. Study completion10 May 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01823510
Sponsor's protocol ID
GCO 13-0208
Status last verified
Dec 2017
First submitted
29 Mar 2013
Last updated
8 Dec 2017
Data monitoring committee
No

Publications

  • 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.

    PubMed 28837213

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ticagrelor + Aspirin and Clopidogrel + Aspirin in people with Type-2 Diabetes Mellitus and Coronary Artery Disease, run by Juan J Badimon at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Thrombus Formation (time frame: up to 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01823510, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2017.

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