Comparison of ticagrelor and clopidogrel in patients with diabetes mellitus and ischemic heart disease

Comparison of TIcagrelor and clopidogrel in patients with Coronary artery diseaSe and type 2 Diabetes Mellitus (TICS-DM): a randomized pharmacodynamic study - TICS-DM

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001661-27-ES

Enrollment

Unknown

Registered

2014-10-16

Start date

2014-12-12

Completion date

Unknown

Last updated

2016-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease

Interventions

Trade Name: Brilique 90mg film-coated tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ticagrelor Other descriptive name: TICAGRELOR Concentration unit: mg milligram(s) Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures 2. Age between 18 and 75 years 3. Type 2 diabetes mellitus according to ADA criteria 4. Angiographically documented coronary artery disease 5. Chronic treatment (>1 month) with aspirin (100mg/day) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: 1. Known allergies to aspirin, clopidogrel, or ticagrelor 2. Blood dyscrasia or bleeding diathesis 3. Any recent acute coronary syndrome (2.5 times the upper limit of normality 12. Pregnant or childbearing females

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the present study is to compare platelet inhibitory effects achieved after one week of treatment with ticagrelor versus clopidogrel, both on top of aspirin therapy, in patients with type 2 diabetes mellitus and coronary artery disease;Secondary Objective: 1. To assess the pharmacodynamic impact of ticagrelor and clopidogrel loading and maintenance doses in type 2 diabetes mellitus patients, measured with different platelet function assays 2. To compare the percentage of patients with low-responsiveness to either ticagrelor or clopidogrel therapy.;Primary end point(s): The primary endpoint is the comparison of the degree of maximal platelet aggregation, measured with light transmittance aggregometry (using 20 ?M ADP as agonist), achieved after 1 week of treatment;Timepoint(s) of evaluation of this end point: After 1 week of treatment with ticagrelor compared to clopidogrel	—

Measure

Time frame

Main Objective: The primary objective of the present study is to compare platelet inhibitory effects achieved after one week of treatment with ticagrelor versus clopidogrel, both on top of aspirin therapy, in patients with type 2 diabetes mellitus and coronary artery disease;Secondary Objective: 1. To assess the pharmacodynamic impact of ticagrelor and clopidogrel loading and maintenance doses in type 2 diabetes mellitus patients, measured with different platelet function assays 2. To compare the percentage of patients with low-responsiveness to either ticagrelor or clopidogrel therapy.;Primary end point(s): The primary endpoint is the comparison of the degree of maximal platelet aggregation, measured with light transmittance aggregometry (using 20 ?M ADP as agonist), achieved after 1 week of treatment;Timepoint(s) of evaluation of this end point: After 1 week of treatment with ticagrelor compared to clopidogrel

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Secondary

Measure	Time frame
Secondary end point(s): Assessment of platelet reactivity after 1 week of treatment with ticagrelor compared with clopidogrel (maintenance dose) measured by: a) Analysis of phosphorilation of vasodilator-stimulated phosphoprotein; b) VerifyNow system; c) Multiple electrode aggregometry Assesment of platelet reactivity after a loading dose of ticagrelor compared to clopidogrel with all platelet funtion assays performed;Timepoint(s) of evaluation of this end point: Loading dose: 2 hours and 24 hours Maintenance dose: 1 week	—

Measure

Time frame

Secondary end point(s): Assessment of platelet reactivity after 1 week of treatment with ticagrelor compared with clopidogrel (maintenance dose) measured by: a) Analysis of phosphorilation of vasodilator-stimulated phosphoprotein; b) VerifyNow system; c) Multiple electrode aggregometry Assesment of platelet reactivity after a loading dose of ticagrelor compared to clopidogrel with all platelet funtion assays performed;Timepoint(s) of evaluation of this end point: Loading dose: 2 hours and 24 hours Maintenance dose: 1 week

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Countries

Spain

Contacts

Public ContactAsuntos científicos e investigación

Sociedad Española de Cardiología

ifernandez@secardiologia.es34917242370237

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026