ST Elevation (STEMI) Myocardial InfarctionPhase 2HEROS-PCINCT06924684
High-Dose Rosuvastatin Preloading for Enhanced Outcomes in STEMI Patients Undergoing Primary PCI
A Phase 2 study testing Statin monotherapy (rosuvastatin or atorvastatin) in people with ST Elevation (STEMI) Myocardial Infarction, run by Sheikh Zayed Federal Postgraduate Medical Institute at 2 sites in Pakistan.
Trial summary
To compare the efficacy of high dose rosuvastatin preloading vs placebo before primary PCI in terms of MACE at 30 days Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ST Elevation (STEMI) Myocardial Infarction
- What is being tested?
- Statin monotherapy (rosuvastatin or atorvastatin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 2 sitesPakistan
- Study dates
- 2 Dec 2024to 2 Jul 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years Patients undergoing primary angiography
Who cannot join
- Hemodynamically unstable patients. History or clinical evidence of any co-morbidities. Taking any medications regularly even statins.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Shaikh Zayed Hsopital
Lahore, 54600
Punjab Institute of Cardiology
Lahore
About this study
Official title: 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
- Being tested
- Statin monotherapy (rosuvastatin or atorvastatin), Placebo
- Medical subject headings
- ST Elevation Myocardial Infarction, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Statin monotherapy (rosuvastatin or atorvastatin)Drug
Also called Rosuvastatins
Tab Rosuvastatin 40mg (weight) at presentation. Tab Rosuvastatin 20mg at night for 30 days.
PlaceboDrug
Placebo caspule
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Active comparator | Tab Rosuvastatin 40mg at presentation. Tab Rosuvastatin 20mg at night for 30 days. Receives: Drug: Statin monotherapy (rosuvastatin or atorvastatin) |
| Placebo Arm | Placebo comparator | Placebo capsule 40mg (weight) at presentation. Tab Rosuvastatin 20mg at night for 30 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of MACE
Measured: 30 days
In-Hospital mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start2 Dec 2024
- Primary completion23 Jun 2025 (estimated)
- Study completion2 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation (STEMI) Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Federal Postgraduate Medical Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Punjab Institute of Cardology
- Responsible party
- Principal investigator, Sohaib Ashraf, Sheikh Zayed Federal Postgraduate Medical Institute
- Investigators
- Sohaib Ashraf, MD, Principal investigator, Shaikh Zayed Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924684
- Sponsor's protocol ID
- UHS/IRB/0156/2024
- Acronym
- HEROS-PCI
- Status last verified
- Dec 2024
- First submitted
- 30 Dec 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of High-Dose Rosuvastatin Preloading Before Primary Percutaneous Coronary Intervention In Patients Suffering From St-Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06924684
- Acronym / sponsor ID
- HEROS-PCI / UHS/IRB/0156/2024
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Sheikh Zayed Federal Postgraduate Medical InstituteUniversity, hospital or other
- Collaborators
- Punjab Institute of Cardology
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 23 Jun 2025 (estimated)
- Study completion
- 2 Jul 2025 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy of high dose rosuvastatin preloading vs placebo before primary PCI in terms of MACE at 30 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Active comparator | Drug: Statin monotherapy (rosuvastatin or atorvastatin)Tab Rosuvastatin 40mg at presentation. Tab Rosuvastatin 20mg at night for 30 days. |
| Placebo Arm | Placebo comparator | Drug: PlaceboPlacebo capsule 40mg (weight) at presentation. Tab Rosuvastatin 20mg at night for 30 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-75 years Patients undergoing primary angiography
Key exclusion criteria (1 listed)
- Hemodynamically unstable patients. History or clinical evidence of any co-morbidities. Taking any medications regularly even statins.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Statin monotherapy (rosuvastatin or atorvastatin)Also: RosuvastatinsTab Rosuvastatin 40mg (weight) at presentation. Tab Rosuvastatin 20mg at night for 30 days. | Drug | Intervention arm |
| PlaceboPlacebo caspule | Drug | Placebo Arm |
Primary outcome
Incidence of MACE
Time frame: 30 days
In-Hospital mortality
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sohaib Ashraf, MD principal investigator
Shaikh Zayed Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Statin monotherapy (rosuvastatin or atorvastatin) in people with ST Elevation (STEMI) Myocardial Infarction, run by Sheikh Zayed Federal Postgraduate Medical Institute at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of MACE (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.