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

Platelet Reactivity Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02808039
• Other study ID #: RMC 2016-3
• Status: Not yet recruiting
• Phase: N/A
• First received: June 17, 2016
• Last updated: June 17, 2016
• Start date: September 2016

Study information

• Verified date: June 2016
• Source: Rabin Medical Center
• Contact: Guy Witberg, MD
• Phone: (+972)528478828
• Email: vitberguy[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dual Antiplatelet Therapy
• Platelet Reactivity

Intervention

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)

Locations

Country	Name	City	State
Israel	Rabin Medical Center - Hsharon Campus	Petach-Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	platelet reactivity		from 1 week prior to 12 weeks post DAPT cessation	No