EndoTic - Endothelium and Ticagrelor

Fundación Investigación Sanitaria en León

Status: Completed

Conditions: Acute Coronary Syndrome (ACS)

Treatments: Drug: Ticagrelor vs Clopidogrel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02244710

2013-005042-11 (EudraCT Number)

ISSBRIL0205

Details and patient eligibility

About

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).

Full 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

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

109 participants in 2 patient groups

Ticagrelor

Experimental group

Description:

180mg initial dose next day 90mg BID

Treatment:

Drug: Ticagrelor vs Clopidogrel

Clopidogrel

Active Comparator group

Description:

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

Treatment:

Drug: Ticagrelor vs Clopidogrel