Complication of Cardiac DefibrillatorNCT02331511
Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator
A study testing Aspirin 80 mg daily and Clopidogrel 75 mg daily in people with Complication of Cardiac Defibrillator and Disorder of Cardiac Pacemaker System, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine whether Aspirin or Clopidogrel are effective in the prevention of venous obstruction after implantation of cardiac pacemaker or defibrillator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication of Cardiac Defibrillator, Disorder of Cardiac Pacemaker System, Venous Occlusion
- What is being tested?
- Aspirin 80 mg daily and Clopidogrel 75 mg daily
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIran
- Study dates
- Oct 2015to Jun 2016
- Phase
- Interventional
- 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
Who may be able to join
- patients who referred for first implantation of pacemaker, implantable cardiac defibrillator, or cardiac re synchronization therapy device
Who cannot join
- history of malignancy
- history of coagulopathy or platelet disorder
- history of venous thromboembolism
- history of gastrointestinal hemorrhage or active gastroduodenal ulcer in past 6 months
- history of chronic kidney disorder or serum creatinine more than 1.5 mg/dl
- patients who are on anticoagulant or other antithrombotic drugs or who must be on dual antiplatelet therapy.
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Shahid ModaressHospital
Tehran, Tehran Province
Mohammad Ali Akbarzadeh, M.D, (+98)9173171001, akbarzadehali@yahoo.com
Mohammad Ali Akbarzadeh, M.D
About this study
Official title: Effect of Aspirin and Clopidogrel in Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator
The purpose of this study is to determine whether Aspirin or Clopidogrel are effective in the prevention of venous obstruction after implantation of cardiac pacemaker or defibrillator.
Read the detailed description
There are growing numbers of endocardial permanent pacemakers (PPM) and implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy (CRT) device. Asymptomatic obstruction of the access vein reported to have a high incidence (30-50%) in some studies. This complication can cause some difficulties in follow up procedures such as device upgrading. The purpose of this study is to determine whether Aspirin or Clopidogrel are effective in the prevention of venous obstruction after implantation of cardiac pacemaker or defibrillator.
- Conditions
- Complication of Cardiac Defibrillator, Disorder of Cardiac Pacemaker System, Venous Occlusion
- Being tested
- placebo, Aspirin 80 mg daily, Clopidogrel 75 mg daily
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Also called placebo 1 tablet daily
placebo administration for 3 months after device(PPM,ICD,CRT) implantation
Aspirin 80 mg dailyDrug
Also called Aspirin
Aspirin 80 mg daily administration for 3 months after device(PPM,ICD,CRT) implantation
Clopidogrel 75 mg dailyDrug
Also called Clopidogrel
Clopidogrel administration for 3 months after device(PPM,ICD,CRT) implantation
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | No antiplatelet drug Receives: Drug: placebo |
| Aspirin | Active comparator | Aspirin 80 mg daily Receives: Drug: Aspirin 80 mg daily |
| Clopidogrel | Active comparator | Clopidogrel 75mg daily Receives: Drug: Clopidogrel 75 mg daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venus obstruction(axillary or subclavian vein) more than 50%(measure by venography)
Measured: 3 months
Secondary outcomes (2)
major bleeding
Measured: 3 months
A composite of death of any cause, myocardial infarction, or cerebrovascular accident.
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 posted6 Jan 2015 (estimated)
- Study startOct 2015
- Primary completionMay 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Cardiac DefibrillatorStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Ali Akbarzadeh, Shahid Beheshti University of Medical Sciences
- Investigators
- Morteza Saafi, M.D., Study chair, Shahid Beheshti University of Medical SciencesMohammad Ali Akbarzadeh, M.D., Study director, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331511
- Sponsor's protocol ID
- CVRC100
- Status last verified
- Oct 2015
- First submitted
- 3 Jan 2015
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aspirin and Clopidogrel in Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator
- ClinicalTrials.gov ID
- NCT02331511
- Acronym / sponsor ID
- CVRC100
- Conditions
- Complication of Cardiac Defibrillator, Disorder of Cardiac Pacemaker System, Venous Occlusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 6 Jan 2015 (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.
The purpose of this study is to determine whether Aspirin or Clopidogrel are effective in the prevention of venous obstruction after implantation of cardiac pacemaker or defibrillator.
Detailed description
There are growing numbers of endocardial permanent pacemakers (PPM) and implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy (CRT) device. Asymptomatic obstruction of the access vein reported to have a high incidence (30-50%) in some studies. This complication can cause some difficulties in follow up procedures such as device upgrading. The purpose of this study is to determine whether Aspirin or Clopidogrel are effective in the prevention of venous obstruction after implantation of cardiac pacemaker or defibrillator.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placeboNo antiplatelet drug |
| Aspirin | Active comparator | Drug: Aspirin 80 mg dailyAspirin 80 mg daily |
| Clopidogrel | Active comparator | Drug: Clopidogrel 75 mg dailyClopidogrel 75mg daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who referred for first implantation of pacemaker, implantable cardiac defibrillator, or cardiac re synchronization therapy device
Key exclusion criteria (6 listed)
- history of malignancy
- history of coagulopathy or platelet disorder
- history of venous thromboembolism
- history of gastrointestinal hemorrhage or active gastroduodenal ulcer in past 6 months
- history of chronic kidney disorder or serum creatinine more than 1.5 mg/dl
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 |
|---|---|---|
| placeboAlso: placebo 1 tablet dailyplacebo administration for 3 months after device(PPM,ICD,CRT) implantation | Drug | placebo |
| Aspirin 80 mg dailyAlso: AspirinAspirin 80 mg daily administration for 3 months after device(PPM,ICD,CRT) implantation | Drug | Aspirin |
| Clopidogrel 75 mg dailyAlso: ClopidogrelClopidogrel administration for 3 months after device(PPM,ICD,CRT) implantation | Drug | Clopidogrel |
Primary outcome
Venus obstruction(axillary or subclavian vein) more than 50%(measure by venography)
Time frame: 3 months
2 secondary outcomes
major bleeding
Time frame: 3 months
A composite of death of any cause, myocardial infarction, or cerebrovascular accident.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
Related trials for Complication of Cardiac Defibrillator
Not yet recruiting
Effects of Short-Term Arm Sling Use After Cardiac Implantable Electronic Device Placement
Postoperative Care After Cardiac Implantable Electronic Device Implantation
Not yet recruitingObservational study
Treatment Registry of Arrhythmias, Complications and Electrocardiograms in Arrhythmogenic CardioMyopathies
Arrhythmogenic Cardiomyopathy (AC, ARVD/C), Ventricular Tachycardia (VT)
Not yet recruitingObservational study
Evaluation of Chronic Postsurgical Pain Risk in Patients Undergoing CIED Implantation Using an AID Support System
Pain Measurement, Chronic Pain
RecruitingObservational study
Multimodal and Multidisciplinary Approach to Optimize Diagnostic, Prognostic, and Therapeutic Management of Patients with Non-ischemic Cardiomyopathies and Arrhythmogenic-inflammatory Phenotypes: a Multicenter, Observational, Retrospective and Prospective Registry Study.
Non-ischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM)
RecruitingObservational study
Prospective Köln Bonn Registry for the Extraction of Pacmaker and ICD Leads
Infections, Pacemaker, Artificial
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.
Morteza Saafi, M.D. study chair
Shahid Beheshti University of Medical Sciences
Mohammad Ali Akbarzadeh, M.D. study director
Shahid Beheshti University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin 80 mg daily and Clopidogrel 75 mg daily in people with Complication of Cardiac Defibrillator and Disorder of Cardiac Pacemaker System, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 6 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 29 Oct 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 Iran. 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. Some participants in this study may receive a placebo. 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 Mohammad Ali Akbarzadeh, M.D. (+98 917 317 1001, akbarzadehali@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venus obstruction(axillary or subclavian vein) more than 50%(measure by venography) (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 29 Oct 2015.