Discovering new clinical properties of ticagrelor

Phase 1

• Conditions: Acute coronary syndrome; MedDRA version: 20.0Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-004189-64-IT
• Lead Sponsor: PRM|PRM_DEFAULT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-05
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Subjects older than 18 years old, who experienced an ACS (including STEMI or NSTEMI) at least 30 days before, with an going treatment for at least 30 days with dual anti-platelet therapy consisting of aspirin + commercially available P2Y12 oral inhibitor, including ticagrelor, clopidogrel or prasugrel at on-label maintenance regimen who remained free from bleeding or ischemic recurrences.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

Administration of fibrinolytics or glycoprotein IIb/IIIa inhibitors in the previous 30 days, major surgery within 30 days or any planned surgical intervention, active bleeding or previous clinical relevant bleeding or stroke in the last 6 months, previous 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, pregnant and breastfeeding women, patients taking potent inhibitors of the CYP3A4. Women of childbearing potential must use appropriate contraception to avoid pregnancy during therapy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified