The effect of ticagrelor monotherapy on platelet reactivity

Phase 1

• Conditions: Coronary artery disease previously treated with coronary stenting; MedDRA version: 19.0Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 19.0Level: LLTClassification code 10023024Term: Ischaemic heart diseaseSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-002734-20-GB
• Lead Sponsor: Research and Innovation Department

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-26
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. 1.Patient is treated with dual antiplatelet therapy comprising aspirin and any other P2Y12 blocker such as clopidogrel, prasugrel or ticagrelor
2. The patient is scheduled to stop dual antiplatelet therapy and continue with aspirin monotherapy.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

Exclusion Criteria

1. Contraindication to dual antiplatelet therapy.
2. Interruption of dual antiplatelet therapy because of bleeding events or increased bleeding risk.
3. Contraindications to the use of ticagrelor.
4. Pregnant and or lactating women.
5. Women with child bearing potential (i.e. not sterilised or not post menopausal) who are unwilling to use contraception.
6. Men with a spouse or partner with child bearing potential unless the participant has agreed to use condoms.

Study & Design

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