The Prevention of Thromboembolic Complications Associated With Coil Embolization

August 21, 2022 updated by: Muhammad Hassan

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Umair Rasheed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with ruptured cerebral hemorrhage

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients with any history of sensitivity or reaction to aspirin, or any contraindication for MRI, were excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Aspirin Group
patients were prescribed 75 mg/day of either aspirin for 6 months
patients were prescribed 75 mg/day of either aspirin
Clopidogrel Group
75mg/day prescribed for 6 months
patients were prescribed 75 mg/day of either aspirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High Intensity Areas
Time Frame: at 24 hours
post procedural
at 24 hours
High Intensity Areas
Time Frame: 3 months
Post Procedural
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High Intensity Areas
Time Frame: at 6 months
Post procedural
at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Umair Rasheed, FRCPS, Lahore general hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2017

Primary Completion (Actual)

February 10, 2020

Study Completion (Actual)

December 10, 2020

Study Registration Dates

First Submitted

August 21, 2022

First Submitted That Met QC Criteria

August 21, 2022

First Posted (Actual)

August 23, 2022

Study Record Updates

Last Update Posted (Actual)

August 23, 2022

Last Update Submitted That Met QC Criteria

August 21, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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