NCT06924684

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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

December 2, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 11, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2025

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2025

Completed
Last Updated

April 11, 2025

Status Verified

December 1, 2024

Enrollment Period

7 months

First QC Date

December 30, 2024

Last Update Submit

April 6, 2025

Conditions

ST Elevation (STEMI) Myocardial Infarction

Outcome Measures

Primary Outcomes (2)

  • Incidence of MACE

    30 days

  • In-Hospital mortality

    30 days

Study Arms (2)

Intervention arm

ACTIVE COMPARATOR

Tab Rosuvastatin 40mg at presentation. Tab Rosuvastatin 20mg at night for 30 days.

Drug: Statin monotherapy (rosuvastatin or atorvastatin)

Placebo Arm

PLACEBO COMPARATOR

Placebo capsule 40mg (weight) at presentation. Tab Rosuvastatin 20mg at night for 30 days.

Drug: Placebo

Interventions

Statin monotherapy (rosuvastatin or atorvastatin)DRUG

Tab Rosuvastatin 40mg (weight) at presentation. Tab Rosuvastatin 20mg at night for 30 days.

Also known as: Rosuvastatins
Intervention arm
PlaceboDRUG

Placebo caspule

Placebo Arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-75 years Patients undergoing primary angiography

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shaikh Zayed Hsopital

Lahore, 54600, Pakistan

Location

Punjab Institute of Cardiology

Lahore, Pakistan

Location

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionMyocardial Infarction

Interventions

Rosuvastatin CalciumAtorvastatin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Sohaib Ashraf, MD

    Shaikh Zayed Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Registrar, Deparment of Cardiology, Principal Investigator

Study Record Dates

First Submitted

December 30, 2024

First Posted

April 11, 2025

Study Start

December 2, 2024

Primary Completion

June 23, 2025

Study Completion

July 2, 2025

Last Updated

April 11, 2025

Record last verified: 2024-12

Locations

PA(2)