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

NCT ID: NCT06924684

Last Updated: 2025-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-02

Study Completion Date

2025-07-02

Brief Summary

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

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Detailed Description

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Conditions

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ST Elevation (STEMI) Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Intervention arm

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

Group Type ACTIVE_COMPARATOR

Statin monotherapy (rosuvastatin or atorvastatin)

Intervention Type DRUG

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

Placebo Arm

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo caspule

Interventions

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Statin monotherapy (rosuvastatin or atorvastatin)

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

Intervention Type DRUG

Placebo

Placebo caspule

Intervention Type DRUG

Other Intervention Names

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Rosuvastatins

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Punjab Institute of Cardology

OTHER

Sponsor Role collaborator

Sheikh Zayed Federal Postgraduate Medical Institute

OTHER

Sponsor Role lead

Responsible Party

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Sohaib Ashraf

Senior Registrar, Deparment of Cardiology, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sohaib Ashraf, MD

Role: PRINCIPAL_INVESTIGATOR

Shaikh Zayed Hospital

Locations

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Shaikh Zayed Hsopital

Lahore, , Pakistan

Site Status

Punjab Institute of Cardiology

Lahore, , Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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UHS/IRB/0156/2024

Identifier Type: -

Identifier Source: org_study_id

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