EndoTic - Endothelium and Ticagrelor

Not Applicable

Completed

• Conditions: Acute Coronary Syndrome (ACS)
• Interventions: Drug: Ticagrelor vs Clopidogrel

• Registration Number: NCT02244710
• Lead Sponsor: Fundación Investigación Sanitaria en León

Brief Summary

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

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 Timeline

• Study First Submitted: 2014-09-11
• Study First Submitted QC: 2014-09-17
• Study First Posted: 2014-09-19
• Study Start: 2015-03
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-22
• Last Update Posted: 2016-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ticagrelor	Ticagrelor vs Clopidogrel	180mg initial dose next day 90mg BID
Clopidogrel	Ticagrelor vs Clopidogrel	600mg po initial dose and 75mg qd starting next day

Primary Outcome Measures

Name	Time	Method
Number of cells	1 month visit	EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)

Secondary Outcome Measures

Name	Time	Method
Platelet reactivity	1 month visit	As determined by P2Y12 kits, VerifyNow®

Trial Locations

Locations (3)

Hospital de Leon; 🇪🇸 Leon, Spain

Hospital Universitario de Santiago; 🇪🇸 Santiago de Compostela, La Coruña, Spain

Hospital Universitario de Salamanca; 🇪🇸 Salamanca, Spain