Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02808039
Recruitment Status : Unknown
Verified June 2016 by Guy Witberg, Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 21, 2016
Last Update Posted : June 21, 2016
Sponsor:
Information provided by (Responsible Party):
Guy Witberg, Rabin Medical Center

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
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.

Layout table for study information
Study Type : Observational
Estimated 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 : September 2016
Estimated Primary Completion Date : April 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor

Group/Cohort 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)




Primary Outcome Measures :
  1. platelet reactivity [ Time Frame: from 1 week prior to 12 weeks post DAPT cessation ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent coronary stent implantation and completed 12 months of DAPT regimen with Ticagrelor with no clinical or adverse events.
Criteria

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808039


Contacts
Layout table for location contacts
Contact: Guy Witberg, MD (+972)528478828 vitberguy@gmail.com
Contact: Eli Lev, MD (+972)504065490 elev@tmhs.org

Locations
Layout table for location information
Israel
Rabin Medical Center - Hsharon Campus Not yet recruiting
Petach-Tikva, Israel, 49100
Contact: Guy Witberg, MD    9+972)528478828    vitberguy@gmail.com   
Contact: Eli Lev, MD    9+972)504065490    elev@tmhs.org   
Sponsors and Collaborators
Rabin Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Guy Witberg, MD Rabin Medical Center, Department of Cardiology
Study Director: Eli Lev, MD Rabin Medical Center, Department of Cardiology

Layout table for additonal information
Responsible Party: Guy Witberg, Dr Guy Witberg, MD department of cardiology , Rabin medical centre, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02808039     History of Changes
Other Study ID Numbers: RMC 2016-3
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Layout table for MeSH terms
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs