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

• Conditions: Dual Antiplatelet Therapy; Platelet Reactivity
• Interventions: Other: Platelet reactivity testing

• Registration Number: NCT02808039
• Lead Sponsor: Rabin Medical Center

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2016-06
• Study First Submitted: 2016-06-17
• Study First Submitted QC: 2016-06-17
• Last Update Submitted: 2016-06-17
• Study First Posted: 2016-06-21
• Last Update Posted: 2016-06-21
• Study Start: 2016-09
• Primary Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 .

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DAPT patients	Platelet reactivity testing	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.

Primary Outcome Measures

Name	Time	Method
platelet reactivity	from 1 week prior to 12 weeks post DAPT cessation

Trial Locations

Locations (1)

Rabin Medical Center - Hsharon Campus; 🇮🇱 Petach-Tikva, Israel