Anti-platelet TherapyNCT03601013
Demographical and Clinical Profile of Patients on Dual Antıplatelet Therapy and Mean Precise-DAPT and DAPT Scores in Turkey
An observational study of Anti-platelet Therapy, run by Cardiovascular Academy Society, Turkey at 1 site in Turkey (Türkiye).
Trial summary
Coronary Artery Disease (CAD) is leading cause of death worldwide. Most of them underwent coronary angiography and they have to use dual anti-platelet therapy. As mentioned novel guidelines for CAD, the estimated number of patients requiring dual anti-platelet therapy has increased over time, and DAPT time is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anti-platelet Therapy
- What is being tested?
- Demographical and Clinical Profile of Patients on Dual Antıplatelet Therapy
- How many people
- 963 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 1 Mar 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that have acute coronary syndrome or percutaneous coronary intervention electively and with available admission heamoglobin, white blood cell and creatine clearance data and on dual antiplatelet therapy
Who may be able to join
- Patients that have acute coronary syndrome or percutaneous coronary intervention electively and with available admission heamoglobin, white blood cell and creatine clearance data and on dual antiplatelet therapy
Who cannot join
- Being under eighteen years old
Trial locations and contacts
1 site in 1 country.
About this study
Coronary Artery Disease (CAD) is leading cause of death worldwide. Most of them underwent coronary angiography and they have to use dual anti-platelet therapy. As mentioned novel guidelines for CAD, the estimated number of patients requiring dual anti-platelet therapy has increased over time, and DAPT time is controversial. Acting on the behalf of 2017 ESC focused update on dual anti-platelet therapy in coronary artery disease developed in collaboration with EACTS guideline, this study is amid to determine PRECISE-DAPT score which predicts out of hospital bleeding risk in patients receiving dual anti-platelet treatment and to detect the prevalence of patients with high bleeding risk, and to determine DAPT score which predicts benefit/risk ratio of continuing or discontinuing dual ant-iplatelet therapy after 12 months and to detect the prevalence of patients with high ischemic or hemorrhagic complication risk in centers included in this study.
Read the detailed description
Design
The study is a national, multicenter, non-interventional, observational, prospective registry.
Population
Patients older than 18 years old of age, have acute coronary syndrome or percutaneous coronary intervention electively and with available admission hemoglobin, white blood cell and creatine clearance data will be enrolled for Precise-DAPT,and Patients older than 18 years old of age and completed 12 months of dual anti-platelet therapy without having hemorrhage and ischemic coronary event and with available data of age, history of smoking, presence of diabetes mellitus, history of percutaneous coronary intervention, paclitaxel eluting stent, stent diameter, history of myocardial infarction, saphenous vein graft intervention, ejection fraction or presence of heart failure. Patients that do not approve informed consent will be excluded.
Aim
This study is amid to investigate the demographic and clinical profile of patients with CAD and on dual anti-platelet therapy, mean precise -DAPT and DAPT scores of Turkey.
- Conditions
- Anti-platelet Therapy
- Being tested
- Demographical and Clinical Profile of Patients on Dual Antıplatelet Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Demographical and Clinical Profile of Patients on Dual Antıplatelet TherapyOther
Demographical and Clinical Profile of Patients on Dual Antıplatelet Therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
ischemia
ischemic events of patients on dual antiplatelet therapy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Mar 2018
- Primary completion1 Nov 2018
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-platelet 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
- 963 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiovascular Academy Society, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601013
- Sponsor's protocol ID
- DAPT-TR
- Status last verified
- May 2019
- First submitted
- 27 Mar 2018
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demographical and Clinical Profile of Patients on Dual Antıplatelet Therapy and Mean Precise-DAPT and DAPT Scores in Turkey
- ClinicalTrials.gov ID
- NCT03601013
- Acronym / sponsor ID
- DAPT-TR
- Conditions
- Anti-platelet Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 963 participants (actual)
- Lead sponsor
- Cardiovascular Academy Society, TurkeyUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 26 Jul 2018 (actual)
- 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.
Coronary Artery Disease (CAD) is leading cause of death worldwide. Most of them underwent coronary angiography and they have to use dual anti-platelet therapy. As mentioned novel guidelines for CAD, the estimated number of patients requiring dual anti-platelet therapy has increased over time, and DAPT time is controversial. Acting on the behalf of 2017 ESC focused update on dual anti-platelet therapy in coronary artery disease developed in collaboration with EACTS guideline, this study is amid to determine PRECISE-DAPT score which predicts out of hospital bleeding risk in patients receiving dual anti-platelet treatment and to detect the prevalence of patients with high bleeding risk, and to determine DAPT score which predicts benefit/risk ratio of continuing or discontinuing dual ant-iplatelet therapy after 12 months and to detect the prevalence of patients with high ischemic or hemorrhagic complication risk in centers included in this study.
Detailed description
Design
The study is a national, multicenter, non-interventional, observational, prospective registry.
Population
Patients older than 18 years old of age, have acute coronary syndrome or percutaneous coronary intervention electively and with available admission hemoglobin, white blood cell and creatine clearance data will be enrolled for Precise-DAPT,and Patients older than 18 years old of age and completed 12 months of dual anti-platelet therapy without having hemorrhage and ischemic coronary event and with available data of age, history of smoking, presence of diabetes mellitus, history of percutaneous coronary intervention, paclitaxel eluting stent, stent diameter, history of myocardial infarction, saphenous vein graft intervention, ejection fraction or presence of heart failure. Patients that do not approve informed consent will be excluded.
Aim
This study is amid to investigate the demographic and clinical profile of patients with CAD and on dual anti-platelet therapy, mean precise -DAPT and DAPT scores of Turkey.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that have acute coronary syndrome or percutaneous coronary intervention electively and with available admission heamoglobin, white blood cell and creatine clearance data and on dual antiplatelet therapy
Key inclusion criteria (1 listed)
- Patients that have acute coronary syndrome or percutaneous coronary intervention electively and with available admission heamoglobin, white blood cell and creatine clearance data and on dual antiplatelet therapy
Key exclusion criteria (1 listed)
- Being under eighteen years old
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 |
|---|---|---|
| Demographical and Clinical Profile of Patients on Dual Antıplatelet TherapyDemographical and Clinical Profile of Patients on Dual Antıplatelet Therapy | Other | – |
Primary outcome
ischemia
Time frame: 3 months
ischemic events of patients on dual antiplatelet therapy
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 7 May 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Anti-platelet Therapy, run by Cardiovascular Academy Society, Turkey at 1 site in Turkey (Türkiye).
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 7 May 2019. 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 Turkey (Türkiye). 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?
ischemia (time frame: 3 months). 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 7 May 2019.