Dual Antiplatelet TherapyNCT02808039
Is There a Transient Rebound Effect of Platelet Reactivity Following Cessation of Dual Antiplatelet Therapy With Ticagrelor - a Single Center Prospective Observational Trial
An observational study of Dual Antiplatelet Therapy and Platelet Reactivity, run by Rabin Medical Center at 1 site in Israel.
Trial summary
to assess whether cessation of 12 months DAPT regimen containing Ticagrelor results in a hyperreactive phase of platelet function Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Dual Antiplatelet Therapy, Platelet Reactivity
- What is being tested?
- Platelet reactivity testing
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2016to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent coronary stent implantation and completed 12 months of DAPT regimen with Ticagrelor with no clinical or adverse events.
Who may be able to join
- Age>18
- underwent coronary stent implantation due to ACS
- completed 12 month of DAPT regimen containing Ticagrelor at standard dose (90 mg BID)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Israel1 site
Rabin Medical Center - Hsharon Campus
Petah Tikva, 49100
Guy Witberg, MD, 9+972)528478828, vitberguy@gmail.com
Eli Lev, MD, 9+972)504065490, elev@tmhs.org
About this study
to assess whether cessation of 12 months DAPT regimen containing Ticagrelor results in a hyperreactive phase of platelet function
Read the 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.
- Conditions
- Dual Antiplatelet Therapy, Platelet Reactivity
- Being tested
- Platelet reactivity testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet reactivity testingOther
assessment of platelet aggregation using the VerifyNow purinergic receptor P2Y, G-protein coupled, 12 (P2Y12) platelet function assay (Accumetrics, San Diego, California)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Platelet reactivity testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
platelet reactivity
Measured: from 1 week prior to 12 weeks post DAPT cessation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startSep 2016
- Primary completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dual Antiplatelet TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guy Witberg, Rabin Medical Center
- Investigators
- Guy Witberg, MD, Principal investigator, Rabin Medical Center, Department of CardiologyEli Lev, MD, Study director, Rabin Medical Center, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808039
- Sponsor's protocol ID
- RMC 2016-3
- Status last verified
- Jun 2016
- First submitted
- 17 Jun 2016
- Last updated
- 21 Jun 2016
- Results posted
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02808039
- Acronym / sponsor ID
- RMC 2016-3
- Conditions
- Dual Antiplatelet Therapy, Platelet Reactivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Apr 2017 (estimated)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DAPT patients | – | Other: Platelet reactivity testingPatients 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent coronary stent implantation and completed 12 months of DAPT regimen with Ticagrelor with no clinical or adverse events.
Key inclusion criteria (3 listed)
- Age>18
- underwent coronary stent implantation due to ACS
- completed 12 month of DAPT regimen containing Ticagrelor at standard dose (90 mg BID)
Key exclusion criteria (4 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet reactivity testingassessment of platelet aggregation using the VerifyNow purinergic receptor P2Y, G-protein coupled, 12 (P2Y12) platelet function assay (Accumetrics, San Diego, California) | Other | DAPT patients |
Primary outcome
platelet reactivity
Time frame: from 1 week prior to 12 weeks post DAPT cessation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Witberg, MD principal investigator
Rabin Medical Center, Department of Cardiology
Eli Lev, MD study director
Rabin Medical Center, Department of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dual Antiplatelet Therapy and Platelet Reactivity, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guy Witberg, MD ((+972)528478828, vitberguy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
platelet reactivity (time frame: from 1 week prior to 12 weeks post DAPT cessation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2016.