The Prevention of Thromboembolic Complications Associated... | NCT05512546

Studies
The Prevention of Thromboembolic Complications Associated With Coil Embolization

NCT05512546

Sponsor

Muhammad Hassan

Status

Completed

Last Update Posted

Aug 23, 2022Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Thromboembolic Stroke
Aspirin
Clopidogrel
Coil Embolization
Prevention

Interventions

Aspir-Low Pill

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 10, 2017Actual

Primary Completion Date

Feb 10, 2020Actual

Completion Date

Dec 10, 2020Actual

First Submitted Date

Aug 21, 2022

First Submission Date that Met QC Criteria

Aug 21, 2022

First Posted Date

Aug 23, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2022

Last Update Posted Date

Aug 23, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aspirin Group		patients were prescribed 75 mg/day of either aspirin for 6 months	Drug: Aspir-Low Pill
Clopidogrel Group		75mg/day prescribed for 6 months	Drug: Aspir-Low Pill

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aspir-Low Pill	Drug	patients were prescribed 75 mg/day of either aspirin	Aspirin Group Clopidogrel Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

patients with ruptured cerebral hemorrhage

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Umair Rasheed, FRCPS	Lahore General Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Umair Rasheed		Lahore	Punjab Province	54000	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001241	Aspirin

Ancestor Terms

ID	Term
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives

Browse Leaves

Not provided

Browse Branches

Not provided