Drugs side-effects on prognostic markers

EndoTic ? Endothelium and Ticagrelor: Pharmacological effects beyond antiplatelet effect - ENDOTIC

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005042-11-ES

Enrollment

Unknown

Registered

2014-02-04

Start date

2014-06-11

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

The use of ticagrelor in ACS is related to a reduction in the number of CECs and/or an increase in the number of EPCs from the baseline values as compared with clopidogrel.

Interventions

Trade Name: Ticagrelor Product Name: Ticagrelor Pharmaceutical Form: Tablet INN or Proposed INN: TICAGRELOR CAS Number: 274693-27-5 Current Sponsor code: TICAGRELOR Other descriptive name: TICAGRELOR

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Provision of informed consent prior to any study specific procedures 2.Patients older than 18 years. 3.Males; postmenopausal women or under contraceptive treatment. 4.Clinical diagnosis of ACS + Elevation of myocardial damage diagnostic biomarkers, using the 3rd universal definition of myocardial infarction31 5.Planned early invasive strategy, coronary angiography =65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: 1.Allergy or contraindication to aspirin, clopidogrel or ticagrelor. 2.Bleeding diathesis or very high risk of bleeding. 3.Participation in another study that has not reached the programmed follow-up. 4.Current treatment with oral anticoagulants, thienopyridines or ticagrelor. 5.Limited life expectancy. 6.Planned elective surgery. 7.Failure for completing the study

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the impact of treatment with ticagrelor or clopidogrel in the number of CECs and EPCs in ACS patients, from baseline values to subacute (?48 hours) or chronic (1 month) levels.;Secondary Objective: To analyze platelet reactivity at 3 time points (before establishing dual antiplatelet treatment (DAPT), 48 hours after the last episode of angina and after 1 month on DAPT) and its correlation with the number of CECs and EPCs. This parameter is also a control of the primary antiplatelet effect;Primary end point(s): The clinical variables of each patient included in the study will be recorded in the Case Report Form (CRF) by the investigators or co-investigators from personal interviews or from the medical records. All these variables will be registered in single, local, specific databases;Timepoint(s) of evaluation of this end point: 12 MONTHS	—

Measure

Time frame

Main Objective: To evaluate the impact of treatment with ticagrelor or clopidogrel in the number of CECs and EPCs in ACS patients, from baseline values to subacute (?48 hours) or chronic (1 month) levels.;Secondary Objective: To analyze platelet reactivity at 3 time points (before establishing dual antiplatelet treatment (DAPT), 48 hours after the last episode of angina and after 1 month on DAPT) and its correlation with the number of CECs and EPCs. This parameter is also a control of the primary antiplatelet effect;Primary end point(s): The clinical variables of each patient included in the study will be recorded in the Case Report Form (CRF) by the investigators or co-investigators from personal interviews or from the medical records. All these variables will be registered in single, local, specific databases;Timepoint(s) of evaluation of this end point: 12 MONTHS

—

Secondary

Measure	Time frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Countries

Spain

Contacts

Public ContactArmando Pérez de Prado

Fundación Investigación Sanitaria en León

aperez@secardiologia.es987237683

Outcome results

None listed

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