EndoTic - Endothelium and Ticagrelor

Fundación Investigación Sanitaria en León109 enrolled

Overview

Randomized clinical trial to assess the influence of treatment with ticagrelor or clopidogrel in the number of CECs (Circulating Endothelial Cells) and EPCs (Endothelial Progenitor Cells) in patients with ACS (Acute Coronary Syndrome), from baseline levels to chronic levels (1 month).

ACS Patients in both treatment groups will be assessed: Baseline, 48h and 1 month cell counts will be done for CECs and EPCs Platelet Function at 48h and 1month Adverse Events, ECG and blood testing result will be also collected

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

109

Conditions

Acute Coronary Syndrome (ACS)

Interventions

Ticagrelor vs ClopidogrelDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Willing to sign Informed Consent Form * 18 yr or older * Male and female (post menopause or contraception treatment) * ACS diagnosed with elevation of myocardial infarction biomarkers (as of 3rd Universal Definition of MI) * Planned invasive strategy (coronariography performed within 72hrs after admission) Exclusion Criteria: * Aspirin, clopidogrel or ticagrelor allergy. * Hemorrhagic diathesis or very high risk of bleeding. * Current treatment with oral anticoagulants, thienopyridines or ticagrelor. * Limited life expectancy. * Elective surgery planned. * High chance of not being able to complete the follow-up period.

Locations (3)

Hospital Universitario de Santiago

Santiago de Compostela, La Coruña, Spain

Hospital de Leon

León, Leon, Spain

Hospital Universitario de Salamanca

Salamanca, Spain

Outcomes

Primary Outcomes

Number of cells

EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)

Time frame: Baseline

Number of cells

EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)

Time frame: 48 hours after last chest pain episode

Number of cells

EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)

Time frame: 1 month visit

Secondary Outcomes

Platelet reactivity

As determined by P2Y12 kits, VerifyNow®

Time frame: At the time of coronary angiography

Platelet reactivity

As determined by P2Y12 kits, VerifyNow®

Time frame: 1 month visit

Data from ClinicalTrials.gov

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