NCT06053983

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

September 19, 2023

Last Update Submit

October 15, 2023

Conditions

Mi Q Wave

Outcome Measures

Primary Outcomes (1)

  • Mean Change C-reactive protein

    hs -CRP (mg/l)

    AFTER 4 WEEKS

Study Arms (2)

rosuvastatin 20 mg

EXPERIMENTAL
Device: Turbox CRP kitDrug: rosuvastatin 20 mg,

atorvastatin 40 mg

EXPERIMENTAL
Device: Turbox CRP kitDrug: atorvastatin 40 mg

Interventions

Turbox CRP kitDEVICE

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.

atorvastatin 40 mgrosuvastatin 20 mg
rosuvastatin 20 mg,DRUG

The statin are most commonly used agents for prevention of cardiovascular events and recurrent episodes of ACS. Apart from their anti-lipid actions, statins show pleotropic effects which include their anti-inflammatory role. Atorvastatin and rosuvastatin are both members of statin family and have showed their effectiveness in reduction of inflammatory biomarkers in addition to their lipid lowering effects

rosuvastatin 20 mg
atorvastatin 40 mgDRUG

The statin are most commonly used agents for prevention of cardiovascular events and recurrent episodes of ACS. Apart from their anti-lipid actions, statins show pleotropic effects which include their anti-inflammatory role. Atorvastatin and rosuvastatin are both members of statin family and have showed their effectiveness in reduction of inflammatory biomarkers in addition to their lipid lowering effects

atorvastatin 40 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Patients who will be surgically managed will be also excluded. 3.if coronary revascularization will be planned or anticipated at the time of screening.
  • Pregnant or lactating women. 5.Patients having concomitant infections which cause the rise of inflammatory markers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rawalpindi Medical University

Rawalpindi, Pakistan

Location

MeSH Terms

Interventions

Rosuvastatin CalciumAtorvastatin

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrrolesAzolesHeptanoic AcidsFatty AcidsLipids

Study Officials

  • asma khan

    Rawalpindi Medical College

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. NAIMA SHEHZADI QAZI PGT MD CARDIOLOGY

Study Record Dates

First Submitted

September 19, 2023

First Posted

September 26, 2023

Study Start

January 1, 2023

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

October 17, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)