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EndoTic - Endothelium and Ticagrelor

NCT ID: NCT02244710

Last Updated: 2016-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-09-30

Brief Summary

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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).

Detailed Description

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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

Conditions

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Acute Coronary Syndrome (ACS)

Keywords

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Circulating Endothelial Cells Endothelial Progenitor Cells Acute coronary syndrome (ACS) Ticagrelor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ticagrelor

180mg initial dose next day 90mg BID

Group Type EXPERIMENTAL

Ticagrelor vs Clopidogrel

Intervention Type DRUG

Clopidogrel

600mg po initial dose and 75mg qd starting next day

Group Type ACTIVE_COMPARATOR

Ticagrelor vs Clopidogrel

Intervention Type DRUG

Interventions

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Ticagrelor vs Clopidogrel

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Fundación Investigación Sanitaria en León

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Armando Pérez de Prado, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fundación Investigación Sanitaria en León

M. Belen Vidriales Acosta, MD, PhD

Role: STUDY_DIRECTOR

University of Salamanca

Locations

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Hospital Universitario de Santiago

Santiago de Compostela, La Coruña, Spain

Site Status

Hospital de Leon

León, Leon, Spain

Site Status

Hospital Universitario de Salamanca

Salamanca, , Spain

Site Status

Countries

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Spain

Other Identifiers

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2013-005042-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ISSBRIL0205

Identifier Type: -

Identifier Source: org_study_id