Comparison Between Atorvastatin and Rosuvastatin in Reduc... | NCT06053983

Studies
Comparison Between Atorvastatin and Rosuvastatin in Reduction of Inflammatory Biomarkers in Patients With Acute Coronary Syndrome

NCT06053983

Sponsor

Rawalpindi Medical College

Status

Completed

Last Update Posted

Oct 17, 2023Actual

Enrollment

126Actual

Phase

Phase 4

Conditions

Mi Q Wave

Interventions

Turbox CRP kit
rosuvastatin 20 mg,
atorvastatin 40 mg

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

Oct 2023

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

Jan 1, 2023Actual

Primary Completion Date

Aug 1, 2023Actual

Completion Date

Aug 1, 2023Actual

First Submitted Date

Sep 19, 2023

First Submission Date that Met QC Criteria

Sep 19, 2023

First Posted Date

Sep 26, 2023Actual

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

Oct 15, 2023

Last Update Posted Date

Oct 17, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will help us to compare atorvastatin and rosuvastatin in terms of their ability to reduce biomarkers of inflammation in patients of acute coronary syndrome

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

126Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
rosuvastatin 20 mg	Experimental		Device: Turbox CRP kit Drug: rosuvastatin 20 mg,
atorvastatin 40 mg	Experimental		Device: Turbox CRP kit Drug: atorvastatin 40 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Turbox CRP kit	Device	Quantitative estimation of hs-CRP will be conducted at the beginning of the study and after the treatment period using the Turbox CRP kit, which employs turbidimetry as the method of measurement.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Change C-reactive protein	hs -CRP (mg/l)	AFTER 4 WEEKS

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with age 18 years and above, of both genders, diagnosed with acute coronary syndrome (as per operational definition) who were not taking statins previously.
Patients who sign written informed consent to participate in the study.

Exclusion Criteria:

1.Patients who are taking either statins and/or any other drug which lower serum lipid levels, patients with a history of statin hypersensitivity, patients in whom statins are contraindicated.

2.Patients who will be surgically managed will be also excluded. 3.if coronary revascularization will be planned or anticipated at the time of screening.

4.Pregnant or lactating women. 5.Patients having concomitant infections which cause the rise of inflammatory markers.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
asma khan	Rawalpindi Medical College	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rawalpindi Medical University		Rawalpindi			Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068718	Rosuvastatin Calcium
D000069059	Atorvastatin

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D005464	Fluorobenzenes

Browse Leaves

Not provided

Browse Branches

Not provided