Overview

Hunting for the Off-Target Properties of Ticagrelor on Endothelial Function in Humans (HI-TECH)

Status:
Completed
Trial end date:
2017-02-10
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this randomized, cross-over study, is to ascertain if ticagrelor, but not prasugrel or clopidogrel, is associated to an improved endothelial function as assessed with peripheral arterial tonometry and markers of endothelial function measurement in post-ACS patients.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Erasmus Medical Center
Collaborator:
Covance
Treatments:
Clopidogrel
Prasugrel Hydrochloride
Ticagrelor
Ticlopidine
Criteria
Inclusion Criteria:

- Patients older than 18 years.

- Patients who experienced an Acute Coronary Syndrome (including STEMI or NSTEMI) at
least 30 days before.

- Patients on ongoing treatment for at least 30 days with dual anti-platelet therapy
consisting of aspirin, at doses of 75-160 mg daily and one commercially available
P2Y12 oral inhibitor , including ticagrelor, clopidogrel or prasugrel.

- Patients who remained free from bleeding (defined as BARC type 2 or greater) or
ischemic recurrences.

- Signed informed consent All inclusion criteria are required.

Exclusion Criteria:

- Administration of fibrinolytics or glycoprotein IIb/IIIa inhibitors in the previous 30
days.

- Major surgery within 30 days or any planned surgical or percutaneous intervention.

- Active bleeding or previous clinical relevant bleeding or stroke in the last 6 months.

- Previous transient ischemic attack or intracranial bleeding.

- Thrombocytopenia.

- Oral anticoagulant therapy.

- Vasculitis or any know immunological disorder.

- Severe hepatic failure.

- Uncontrolled hypertension (systolic or diastolic arterial pressure >180 mmHg or 120,
respectively, despite medical therapy).

- Known intolerance to aspirin or to clopidogrel or prasugrel or ticagrelor.

- Limited life expectancy, e.g. neoplasms, others.

- Inability to obtain informed consent.

- Pregnancy.