Is There a Transient Rebound Effect of Platelet Reactivity Following Cessation of Dual Antiplatelet Therapy With Ticagrelor - a Single Center Prospective Observational Trial

Clalit Health Services

Status: Unknown

Conditions: Platelet Reactivity; Dual Antiplatelet Therapy

Treatments: Other: Platelet reactivity testing

Study type: Observational

Funder types: Other

Identifiers

NCT02808039

RMC 2016-3

Details and patient eligibility

About

to assess whether cessation of 12 months DAPT regimen containing Ticagrelor results in a hyperreactive phase of platelet function

Full description

the study will be composed of a cohort of patients , who completed 12 months of DAPT with Ticagrelor (standard recommended dose for ACS - 90 mg BID), did not experience any clinical or adverse event during this time period and are about to discontinue Ticagrelor. We intend to measure the platelet reactivity for each patient on 4 time points - prior to cessation of Ticagrelor (i.e. while still on DAPT) and 1,4 and 12 weeks post discontinuation of therapy. There will not be a control group.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age>18
• underwent coronary stent implantation due to ACS
• completed 12 month of DAPT regimen containing Ticagrelor at standard dose (90 mg BID)

Exclusion criteria

• any ischemic or bleeding events while under Ticagrelor
• any other Ticagrelor associated adverse effects
• planned for continuation of Ticagrelor for more than 12months post stenting according to the judgment of the attending physician.
• Unable to make informed consent .

Trial design

60 participants in 1 patient group

DAPT patients

Description:

Patients planned for cessation of DAPT regimen containing Ticagrelor after 12 months of treatment following coronary stent implantation . the platelet reactivity will be assessed 1 week prior to cessation of DAPT and than at 1,3,and 12 weeks post DAPT cessation.

Treatment:

Other: Platelet reactivity testing