PCIBRILIQUENCT02297971
Assessment of Coagulation and Thrombocyte Function After Termination of Ticagrelor
An observational study of PCI and Coronary Stents, run by Örebro University, Sweden at 1 site in Sweden.
Trial summary
When ticagrelor should be discontinued prior to elective surgery is unclear. The risks of bleeding when it is continued peri-operatively have to be weighed against the risk of coronary artery thrombosis when stopped. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- PCI, Coronary Stents
- How many people
- 25 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2013to Sep 2015
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have previously had a coronary artery syndrome treated by PCI and stent placement and who are taking the oral anti platelet drugs aspirin and ticagrelor would be included into the study.
Who may be able to join
- Patients who are on the Cardiology Clinic's database at the University Hospital, Örebro and shall terminate ticagrelor after one year following PCI and stent placement would be identified and offered to take part in this study.
Who cannot join
- Non-responders (not partial responders) to ticagrelor would be excluded from the study. Additionally, patients who are either taking NSAID's regularly or during the last 2 weeks prior to study start would also be excluded as those who have language or cognitive limitations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Coagulation and Thrombocyte Function After Termination of Ticagrelor in Patients Who Have Previously Undergone PCI Procedures and Insertion of Coronary Stents
When ticagrelor should be discontinued prior to elective surgery is unclear. The risks of bleeding when it is continued peri-operatively have to be weighed against the risk of coronary artery thrombosis when stopped. This study aims to assess coagulation and thrombocyte function every other day in patients who are taking ticagrelor after coronary artery stents and discontinue therapy at the end of one year.
Read the detailed description
Patients who have an acute coronary syndrome are today often treated by percutaneous coronary intervention (PCI) and insertion of one or several coronary stents. Subsequently, these patients are treated with oral anti-platelet (OAP) drugs, usually a combination of acetyl salicylic acid (aspirin) and clopidogrel/ticagrelor. Although aspirin is continued for a life-long period, clopidogrel/ticagrelor are used for a variable period of time, often from 3 months - 1 year after PCI, depending on the type of stent. Interventional elective non-cardiac surgery during the time of clopidogrel/ticagrelor therapy is not recommended except for life-threatening (acute surgery) or life-prolonging (cancer surgery) procedures. Specifically for life-prolonging procedures, surgery can be planned, and therefore the question often arises as to when OAPs should be terminated prior to planned surgery. This decision rests on balancing the risks of bleeding (when continued) or coronary stent thrombosis (when stopped). Certainly, because of the small risk of severe bleeding when using aspirin, this drug should be continued throughout the perioperative period in patients with coronary stents. However, continuing clopidogrel/ticagrelor is more controversial since severe perioperative bleeding is difficult to reverse in these patients. Therefore, surgeons would normally discontinue clopidogrel/ticagrelor prior to surgery, specifically when the potential for bleeding is high, and the consequences major. The exact duration for which these drugs should be discontinued remains unclear and, depending on the drug used, a period of 3 - 5 days is generally recommended, based on the pharmacokinetics and dynamics of clopidogrel/ticagrelor in otherwise healthy patients.
This study was done to better understand coagulation and thrombocyte function immediately before discontinuation of ticagrelor and at regular intervals after termination, in patients who have previously undergone PCI, have coronary stents, are taking ticagrelor but discontinue it after one-year of therapy in accordance with hospital routines. No surgical intervention was planned in these patients after termination of ticagrelor.
- Conditions
- PCI, Coronary Stents
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet aggregometry
Platelet aggregometry using Multiplate assay would be done prior to termination of ticagrelor treatment and thereafter every other day of 10 days.
Measured: 0 - 10 days
Secondary outcomes (2)
Thromboelstography
Thromboelastography would be performed prior to termination of ticagrelor treatment and thereafter every other day of 10 days.
Measured: 0-10 days
Coagulation function tests
Coagulation function would be performed on alternate days starting before termination of ticagrelor.
Measured: 0-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startSep 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCIStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anil Gupta, Örebro University, Sweden
- Investigators
- Anil Gupta, MD, PhD, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297971
- Sponsor's protocol ID
- 2013/001
- Acronym
- BRILIQUE
- Status last verified
- Sep 2015
- First submitted
- 18 Nov 2014
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Coagulation and Thrombocyte Function After Termination of Ticagrelor in Patients Who Have Previously Undergone PCI Procedures and Insertion of Coronary Stents
- ClinicalTrials.gov ID
- NCT02297971
- Acronym / sponsor ID
- BRILIQUE / 2013/001
- Conditions
- PCI, Coronary Stents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 21 Nov 2014 (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.
When ticagrelor should be discontinued prior to elective surgery is unclear. The risks of bleeding when it is continued peri-operatively have to be weighed against the risk of coronary artery thrombosis when stopped. This study aims to assess coagulation and thrombocyte function every other day in patients who are taking ticagrelor after coronary artery stents and discontinue therapy at the end of one year.
Detailed description
Patients who have an acute coronary syndrome are today often treated by percutaneous coronary intervention (PCI) and insertion of one or several coronary stents. Subsequently, these patients are treated with oral anti-platelet (OAP) drugs, usually a combination of acetyl salicylic acid (aspirin) and clopidogrel/ticagrelor. Although aspirin is continued for a life-long period, clopidogrel/ticagrelor are used for a variable period of time, often from 3 months - 1 year after PCI, depending on the type of stent. Interventional elective non-cardiac surgery during the time of clopidogrel/ticagrelor therapy is not recommended except for life-threatening (acute surgery) or life-prolonging (cancer surgery) procedures. Specifically for life-prolonging procedures, surgery can be planned, and therefore the question often arises as to when OAPs should be terminated prior to planned surgery. This decision rests on balancing the risks of bleeding (when continued) or coronary stent thrombosis (when stopped). Certainly, because of the small risk of severe bleeding when using aspirin, this drug should be continued throughout the perioperative period in patients with coronary stents. However, continuing clopidogrel/ticagrelor is more controversial since severe perioperative bleeding is difficult to reverse in these patients. Therefore, surgeons would normally discontinue clopidogrel/ticagrelor prior to surgery, specifically when the potential for bleeding is high, and the consequences major. The exact duration for which these drugs should be discontinued remains unclear and, depending on the drug used, a period of 3 - 5 days is generally recommended, based on the pharmacokinetics and dynamics of clopidogrel/ticagrelor in otherwise healthy patients.
This study was done to better understand coagulation and thrombocyte function immediately before discontinuation of ticagrelor and at regular intervals after termination, in patients who have previously undergone PCI, have coronary stents, are taking ticagrelor but discontinue it after one-year of therapy in accordance with hospital routines. No surgical intervention was planned in these patients after termination of ticagrelor.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have previously had a coronary artery syndrome treated by PCI and stent placement and who are taking the oral anti platelet drugs aspirin and ticagrelor would be included into the study.
Key inclusion criteria (1 listed)
- Patients who are on the Cardiology Clinic's database at the University Hospital, Örebro and shall terminate ticagrelor after one year following PCI and stent placement would be identified and offered to take part in this study.
Key exclusion criteria (1 listed)
- Non-responders (not partial responders) to ticagrelor would be excluded from the study. Additionally, patients who are either taking NSAID's regularly or during the last 2 weeks prior to study start would also be excluded as those who have language or cognitive limitations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Platelet aggregometry
Time frame: 0 - 10 days
Platelet aggregometry using Multiplate assay would be done prior to termination of ticagrelor treatment and thereafter every other day of 10 days.
2 secondary outcomes
Thromboelstography
Time frame: 0-10 days
Coagulation function tests
Time frame: 0-10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2015.
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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.
Anil Gupta, MD, PhD principal investigator
Örebro University, Sweden
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 PCI and Coronary Stents, run by Örebro University, Sweden at 1 site in Sweden.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Sep 2015. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet aggregometry (time frame: 0 - 10 days). 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 29 Sep 2015.