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Completed

NCT Number: NCT02244710

EndoTic - Endothelium and Ticagrelor

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).

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Key information

Conditions

Acute Coronary Syndrome (ACS) Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario de Santiago, Santiago de Compostela, La Coruña, Spain

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ticagrelor vs Clopidogrel

Drug

Primary outcomes

  1. Number of cells

    Time frame: Baseline

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

  2. Number of cells

    Time frame: 48 hours after last chest pain episode

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

  3. Number of cells

    Time frame: 1 month visit

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

Secondary outcomes

  1. Platelet reactivity

    Time frame: At the time of coronary angiography

    As determined by P2Y12 kits, VerifyNow®

  2. Platelet reactivity

    Time frame: 1 month visit

    As determined by P2Y12 kits, VerifyNow®

Other outcomes

  1. Safety: Bleeding and ischemic adverse events

    Time frame: 18 months (Study duration)

    Adverse Events collection

Sponsors and collaborators

Lead sponsor

Fundación Investigación Sanitaria en León

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

EndoTic - Endothelium and Ticagrelor: Pharmacological Effects Beyond Antiplatelet Therapy

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 19, 2014
Registry last updated
Nov 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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