Thromboembolic StrokeNCT05512546
The Prevention of Thromboembolic Complications Associated With Coil Embolization
An observational study of Thromboembolic Stroke and Aspirin, run by Muhammad Hassan at 1 site in Pakistan.
Trial summary
Clopidogrel has been to be reported to be superior to aspirin for the prevention of thromboembolic complications associated with coil embolization in patients with ruptured aneurysms. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Thromboembolic Stroke, Aspirin, Clopidogrel
- What is being tested?
- Aspir-Low Pill
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Feb 2017to 10 Dec 2020
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with ruptured cerebral hemorrhage
Who may be able to join
- All the patients enrolled in the study underwent MRI and Angiography.
- Participants included in the study were confirmed on assessment, and verified for ruptured aneurysm by imaging using either computed tomography (CT) or MRI.
Who cannot join
- Patients with any history of sensitivity or reaction to aspirin, or any contraindication for MRI, were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coil Embolization and Thromboembolic Complications in Patients With Ruptured Aneurysms
Clopidogrel has been to be reported to be superior to aspirin for the prevention of thromboembolic complications associated with coil embolization in patients with ruptured aneurysms.
- Conditions
- Thromboembolic Stroke, Aspirin, Clopidogrel, Coil Embolization, Prevention
- Being tested
- Aspir-Low Pill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspir-Low PillDrug
patients were prescribed 75 mg/day of either aspirin
| Study group | Role | What they receive |
|---|---|---|
| Aspirin Group | patients were prescribed 75 mg/day of either aspirin for 6 months Receives: Drug: Aspir-Low Pill | |
| Clopidogrel Group | 75mg/day prescribed for 6 months Receives: Drug: Aspir-Low Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
High Intensity Areas
post procedural
Measured: at 24 hours
High Intensity Areas
Post Procedural
Measured: 3 months
Secondary outcomes (1)
High Intensity Areas
Post procedural
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start10 Feb 2017
- Primary completion10 Feb 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thromboembolic StrokeStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Hassan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Hassan, Shaheed Zulfiqar Ali Bhutto Medical University
- Investigators
- Umair Rasheed, FRCPS, Study director, Lahore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512546
- Sponsor's protocol ID
- Lahore General Hospital
- Status last verified
- Aug 2022
- First submitted
- 21 Aug 2022
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coil Embolization and Thromboembolic Complications in Patients With Ruptured Aneurysms
- ClinicalTrials.gov ID
- NCT05512546
- Acronym / sponsor ID
- Lahore General Hospital
- Conditions
- Thromboembolic Stroke, Aspirin, Clopidogrel, Coil Embolization, Prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Muhammad HassanUniversity, hospital or other
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 23 Aug 2022 (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.
Clopidogrel has been to be reported to be superior to aspirin for the prevention of thromboembolic complications associated with coil embolization in patients with ruptured aneurysms.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin Group | – | Drug: Aspir-Low Pillpatients were prescribed 75 mg/day of either aspirin for 6 months |
| Clopidogrel Group | – | Drug: Aspir-Low Pill75mg/day prescribed for 6 months |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with ruptured cerebral hemorrhage
Key inclusion criteria (2 listed)
- All the patients enrolled in the study underwent MRI and Angiography.
- Participants included in the study were confirmed on assessment, and verified for ruptured aneurysm by imaging using either computed tomography (CT) or MRI.
Key exclusion criteria (1 listed)
- Patients with any history of sensitivity or reaction to aspirin, or any contraindication for MRI, were excluded from the study.
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 |
|---|---|---|
| Aspir-Low Pillpatients were prescribed 75 mg/day of either aspirin | Drug | Aspirin Group, Clopidogrel Group |
Primary outcome
High Intensity Areas
Time frame: at 24 hours
post procedural
High Intensity Areas
Time frame: 3 months
Post Procedural
1 secondary outcome
High Intensity Areas
Time frame: at 6 months
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 23 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
Umair Rasheed, FRCPS study director
Lahore General Hospital
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 Thromboembolic Stroke and Aspirin, run by Muhammad Hassan at 1 site in Pakistan.
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 2 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 23 Aug 2022. 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 Pakistan. 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?
High Intensity Areas (time frame: at 24 hours). The study lists 2 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 23 Aug 2022.