High-Dose Rosuvastatin Preloading for Enhanced Outcomes in STEMI Patients Undergoing Primary PCI (HEROS-PCI)

April 6, 2025 updated by: Sohaib Ashraf, Sheikh Zayed Federal Postgraduate Medical Institute

Efficacy Of High-Dose Rosuvastatin Preloading Before Primary Percutaneous Coronary Intervention In Patients Suffering From St-Elevation Myocardial Infarction

To compare the efficacy of high dose rosuvastatin preloading vs placebo before primary PCI in terms of MACE at 30 days

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Phase 2

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

  • Pakistan
      • Lahore, Pakistan, 54600
        • Shaikh Zayed Hsopital
      • Lahore, Pakistan
        • Punjab Institute of Cardiology

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-75 years Patients undergoing primary angiography

Exclusion Criteria:

  • Hemodynamically unstable patients. History or clinical evidence of any co-morbidities. Taking any medications regularly even statins.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention arm
Tab Rosuvastatin 40mg at presentation. Tab Rosuvastatin 20mg at night for 30 days.
Drug: Statin monotherapy (rosuvastatin or atorvastatin)
Tab Rosuvastatin 40mg (weight) at presentation. Tab Rosuvastatin 20mg at night for 30 days.
Other Names:
  • Rosuvastatins
Placebo Comparator: Placebo Arm
Placebo capsule 40mg (weight) at presentation. Tab Rosuvastatin 20mg at night for 30 days.
Drug: Placebo
Placebo caspule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of MACE
Time Frame: 30 days
30 days
In-Hospital mortality
Time Frame: 30 days
30 days

Collaborators and Investigators

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

Sponsor

Sheikh Zayed Federal Postgraduate Medical Institute

Collaborators

Punjab Institute of Cardology

Investigators

  • Principal Investigator: Sohaib Ashraf, MD, Shaikh Zayed 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)

December 2, 2024

Primary Completion (Estimated)

June 23, 2025

Study Completion (Estimated)

July 2, 2025

Study Registration Dates

First Submitted

December 30, 2024

First Submitted That Met QC Criteria

April 6, 2025

First Posted (Actual)

April 11, 2025

Study Record Updates

Last Update Posted (Actual)

April 11, 2025

Last Update Submitted That Met QC Criteria

April 6, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHS/IRB/0156/2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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