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

• Sponsor: Rabin Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02808039
• Collaborator: (none)
• Enrollment: 60
• Location: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dual Antiplatelet Therapy; Platelet Reactivity	Other: Platelet reactivity testing

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 Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Is There a Transient Rebound Effect of Platelet Reactivity Following Cessation of Dual Antiplatelet Therapy With Ticagrelor - a Single Center Prospective Observational Trial
• Study Start Date: Sep 1, 2016
• Anticipated Primary Completion Date: Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
DAPT patients 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.	Other: Platelet reactivity testing; assessment of platelet aggregation using the VerifyNow purinergic receptor P2Y, G-protein coupled, 12 (P2Y12) platelet function assay (Accumetrics, San Diego, California)

Outcome Measures

Primary Outcome Measures

1. platelet reactivity [from 1 week prior to 12 weeks post DAPT cessation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 .

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rabin Medical Center - Hsharon Campus	Petach-Tikva		Israel	49100

Sponsors and Collaborators

• Rabin Medical Center

Investigators

• Principal Investigator: Guy Witberg, MD, Rabin Medical Center, Department of Cardiology
• Study Director: Eli Lev, MD, Rabin Medical Center, Department of Cardiology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guy Witberg, Dr Guy Witberg, MD department of cardiology , Rabin medical centre, Rabin Medical Center
• ClinicalTrials.gov Identifier: NCT02808039
• Other Study ID Numbers: RMC 2016-3
• First Posted: Jun 21, 2016
• Last Update Posted: Jun 21, 2016
• Last Verified: Jun 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes

Study Results

No Results Posted as of Jun 21, 2016