Percutaneous Coronary InterventionNCT02327741
Efficacy of Long Term Plavix Therapy Post Angioplasty
A study testing plavix in people with Percutaneous Coronary Intervention, run by Shiraz University of Medical Sciences.
Trial summary
1010 patients post stenting were enrolled to receive Plavix more than 12 months and less than that and rate of bleeding, complication and major cardiovascular adverse events ( MACE) were compared to evaluate safety and feasibility of long term Plavix therapy post stenting. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Percutaneous Coronary Intervention
- What is being tested?
- plavix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,010 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Oct 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- post stent ( lesion more than 70% and vessel more than 2.25 mm )
Who cannot join
- allergy to acetylsalicylic acid or clopidogrel,
- planned surgery within 24 months of percutaneous coronary intervention unless the dual antiplatelet therapy could be maintained throughout the perisurgical period
- history of bleeding diathesis
- major surgery within 15 days
- active bleeding
- previous stroke in the past 6 months
Show all 9Show fewer
- concomitant or foreseeable need for oral anticoagulation therapy
- pregnancy, life expectancy <24 months, participation in another trial
- inability to provide informed consent
About this study
Official title: Evaluation of Safety, Benefits and Complications of Long-term Dual Antiplatelet Therapy in Patients With Angioplasty
1010 patients post stenting were enrolled to receive Plavix more than 12 months and less than that and rate of bleeding, complication and major cardiovascular adverse events ( MACE) were compared to evaluate safety and feasibility of long term Plavix therapy post stenting.
Read the detailed description
1010 patients from registry of angioplasty and stenting in Shiraz and Baghiatolah hospital were enrolled and long term Plavix therapy more than and less than 12 months were compared between two groups of patients prospectively and rate of major adverse cardiovascular events ( MACE) (death, myocardial infarction, cerebrovascular accidents and revascularization) and rate of bleeding were compared between 2 groups.Syntax score and American heart association ( AHA) score of coronary involvement were measured and MACE was compared to these scores.
- Conditions
- Percutaneous Coronary Intervention
- Being tested
- plavix
- Keywords
- Dual antiplatelet therapy, clopidogrel, percutaneous coronary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plavixDrug
taking plavix more than 12 months
plavixDrug
taking plavix less than 12 months
| Study group | Role | What they receive |
|---|---|---|
| plavix long term | Experimental | taking plavix more than 12 months Receives: Drug: plavix |
| plavix short term | Active comparator | taking plavix less than 12 months Receives: Drug: plavix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Major Bleeding Need Transfusion
number of patients with major bleeding need transfusion
Measured: 12 months
Number of Patients With Myocardial Infarction Need Hospital Admission
The number of patients with myocardial infarction need hospital admission
Measured: 12 month
Number of Patients With Central Vascular Accidents Proved by CT Scan
the number of patients with major vascular brain accidents ( CVA) proved by CT scan
Measured: 12 months
Number of Patients With Death Due to Cardiac Causes
the number patients with death due to cardiac causes
Measured: 12 months
Revascularization - Need for Redo Bypass Surgery and Redo Angioplasty
need for redo bypass surgery and redo angioplasty
Measured: 12 months
Number of Patients With Minor Bleeding
the number of patients with petechiae and superficial ecchymosis or nose bleeding need no admission or drug changes
Measured: 12 months
Secondary outcomes (1)
Tolerability - the Number of Patients , Who Are Able to Take Plavix Concerning Compliance and Economic Issues
the number of patients who are able to take plavix concerning compliance and economic issues
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startOct 2012
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Percutaneous Coronary InterventionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,010 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Baqiyatallah Medical Sciences University
- Responsible party
- Principal investigator, Javad Kojuri, Shiraz University of Medical Sciences
- Investigators
- javad kojuri, M.D. M.S., Principal investigator, shiraz university of medcal sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327741
- Sponsor's protocol ID
- 90-2348
- Status last verified
- Apr 2020
- First submitted
- 13 Dec 2014
- Last updated
- 29 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety, Benefits and Complications of Long-term Dual Antiplatelet Therapy in Patients With Angioplasty
- ClinicalTrials.gov ID
- NCT02327741
- Acronym / sponsor ID
- 90-2348
- Conditions
- Percutaneous Coronary Intervention
- Keywords
- Dual antiplatelet therapy, clopidogrel, percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,010 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Collaborators
- Baqiyatallah Medical Sciences University
- Study start
- Oct 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 30 Dec 2014 (estimated)
- Results
- Posted 29 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
1010 patients post stenting were enrolled to receive Plavix more than 12 months and less than that and rate of bleeding, complication and major cardiovascular adverse events ( MACE) were compared to evaluate safety and feasibility of long term Plavix therapy post stenting.
Detailed description
1010 patients from registry of angioplasty and stenting in Shiraz and Baghiatolah hospital were enrolled and long term Plavix therapy more than and less than 12 months were compared between two groups of patients prospectively and rate of major adverse cardiovascular events ( MACE) (death, myocardial infarction, cerebrovascular accidents and revascularization) and rate of bleeding were compared between 2 groups.Syntax score and American heart association ( AHA) score of coronary involvement were measured and MACE was compared to these scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| plavix long term | Experimental | Drug: plavixtaking plavix more than 12 months |
| plavix short term | Active comparator | Drug: plavixtaking plavix less than 12 months |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- post stent ( lesion more than 70% and vessel more than 2.25 mm )
Key exclusion criteria (9 listed)
- allergy to acetylsalicylic acid or clopidogrel,
- planned surgery within 24 months of percutaneous coronary intervention unless the dual antiplatelet therapy could be maintained throughout the perisurgical period
- history of bleeding diathesis
- major surgery within 15 days
- active bleeding
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 |
|---|---|---|
| plavixtaking plavix more than 12 months | Drug | plavix long term |
| plavixtaking plavix less than 12 months | Drug | plavix short term |
Primary outcome
Number of Patients With Major Bleeding Need Transfusion
Time frame: 12 months
number of patients with major bleeding need transfusion
Number of Patients With Myocardial Infarction Need Hospital Admission
Time frame: 12 month
The number of patients with myocardial infarction need hospital admission
Number of Patients With Central Vascular Accidents Proved by CT Scan
Time frame: 12 months
the number of patients with major vascular brain accidents ( CVA) proved by CT scan
Number of Patients With Death Due to Cardiac Causes
Time frame: 12 months
the number patients with death due to cardiac causes
Revascularization - Need for Redo Bypass Surgery and Redo Angioplasty
Time frame: 12 months
need for redo bypass surgery and redo angioplasty
Number of Patients With Minor Bleeding
Time frame: 12 months
the number of patients with petechiae and superficial ecchymosis or nose bleeding need no admission or drug changes
1 secondary outcome
Tolerability - the Number of Patients , Who Are Able to Take Plavix Concerning Compliance and Economic Issues
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
javad kojuri, M.D. M.S. principal investigator
shiraz university of medcal sciences
Questions about this trial
What is this clinical trial studying?
A study testing plavix in people with Percutaneous Coronary Intervention, run by Shiraz University of Medical Sciences.
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 9 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 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 29 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With Major Bleeding Need Transfusion (time frame: 12 months). The study lists 6 primary outcomes in all. 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 Apr 2020.