Acute Myocardial InfarctionPhase 4IMPRESNCT01050348
To Investigate the Role of Upstream High Dose Statin in STEMI
A Phase 4 study testing Atorvastatin calcium in people with Acute Myocardial Infarction, run by The Western Pennsylvania Hospital at 2 sites in United States.
Trial summary
This is a double-blinded randomized placebo controlled trial investigating the role of upstream 80mg Atorvastastin-calcium in patients undergoing percutaneous intervention for acute STEMI. Read more about this study
- Who is it for?
- Ages 25 to 90 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Atorvastatin calcium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2009to Jun 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 25 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient of 25 to 90 years of age admitted or transferred to Western Pennsylvania Hospital or Allegheny General Hospital with a diagnosis of STEMI undergoing emergent percutaneous intervention (PCI) to the culprit coronary artery. STEMI is defined as greater than 1mm ST segment elevation on electrocardiogram.
- Elevated cardiac biomarkers (troponin-T > 0.03ng/ml, CKMB>5ng/mL, or ck>170 U/l).
Who cannot join
- Known history of liver disease defined as cirrhosis, alcoholic liver disease, Non alcoholic steatohepatitis, hepatitis or any causes of liver failure.
- Renal failure with creatinine >3mg/dL
- Known history of liver or muscle disease such as rheumatologic myopathies, history of myositis, hepatitis, and hepatic cancer.
- Cardiovascular arrest and shock.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
About this study
Official title: A Double Blinded Randomized Placebo Controlled Study: To Investigate the Role of Upstream High Dose Statin Treatment in Patients With ST Segment Elevation Myocardial Infarction
This is a double-blinded randomized placebo controlled trial investigating the role of upstream 80mg Atorvastastin-calcium in patients undergoing percutaneous intervention for acute STEMI.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Atorvastatin calcium, Inactive Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin calciumDrug
Also called Lipitor
Eligible patients will receive 80mgs of atorvastatin orally upon admission to hospital prior to percutaneous intervention of the affected artery. Dose of post-procedural statin will be at the discretion of the cardiologist.
Inactive PlaceboDrug
Also called Placebo, Sugar Pill
Eligible patients will receive a placebo orally upon admission to hospital prior to percutaneous intervention of the affected artery.
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin calcium | Active comparator | Patients will receive study medication upon admission to hospital prior to percutaneous intervention of the culprit artery Receives: Drug: Atorvastatin calcium |
| Sugar Pill | Placebo comparator | Patients will receive study medication upon admission to hospital prior to percutaneous intervention of the culprit artery Receives: Drug: Inactive Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular event (MACE) defined as cardiovascular death, MI, or target revascularization 30 days post percutaneous intervention.
Measured: 15 and 30 days post revascularization
Secondary outcomes (4)
Any increase in mean peak values of CK-MB, troponin I and myoglobin greater than twice the upper limit after intervention.
Measured: 15 and 30 days post revascularization
Any occurrence of major adverse cardiac events defined as death, MI, congestive heart failure, cardiogenic shock or need for unplanned revascularization within 24 hours after procedure or need for emergent CABG.
Measured: 15 and 30 days post revascularization
Symptomatic side effects of current statin medication as described by adverse effects on consent form.
Measured: Immediately post revascularization to 30 days.
Modified Coronary Revascularization Outcome Questionnaire (CROQ-PTCA)
Measured: 15 and 30 days post revascularization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startJun 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Western Pennsylvania Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- West Penn Allegheny Health System
- Responsible party
- Sponsor
- Investigators
- Venkatraman Srinivasan, MD, Principal investigator, West Penn Allegheny Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050348
- Sponsor's protocol ID
- 09-004 / WPCI 2009-08
- Acronym
- IMPRES
- Status last verified
- Oct 2018
- First submitted
- 14 Jan 2010
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blinded Randomized Placebo Controlled Study: To Investigate the Role of Upstream High Dose Statin Treatment in Patients With ST Segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01050348
- Acronym / sponsor ID
- IMPRES / 09-004 / WPCI 2009-08
- Conditions
- Acute Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- The Western Pennsylvania HospitalUniversity, hospital or other
- Collaborators
- West Penn Allegheny Health System
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 15 Jan 2010 (estimated)
- 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.
This is a double-blinded randomized placebo controlled trial investigating the role of upstream 80mg Atorvastastin-calcium in patients undergoing percutaneous intervention for acute STEMI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin calcium | Active comparator | Drug: Atorvastatin calciumPatients will receive study medication upon admission to hospital prior to percutaneous intervention of the culprit artery |
| Sugar Pill | Placebo comparator | Drug: Inactive PlaceboPatients will receive study medication upon admission to hospital prior to percutaneous intervention of the culprit artery |
Who may qualify
- Ages
- 25 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any patient of 25 to 90 years of age admitted or transferred to Western Pennsylvania Hospital or Allegheny General Hospital with a diagnosis of STEMI undergoing emergent percutaneous intervention (PCI) to the culprit coronary artery. STEMI is defined as greater than 1mm ST segment elevation on electrocardiogram.
- Elevated cardiac biomarkers (troponin-T > 0.03ng/ml, CKMB>5ng/mL, or ck>170 U/l).
Key exclusion criteria (4 listed)
- Known history of liver disease defined as cirrhosis, alcoholic liver disease, Non alcoholic steatohepatitis, hepatitis or any causes of liver failure.
- Renal failure with creatinine >3mg/dL
- Known history of liver or muscle disease such as rheumatologic myopathies, history of myositis, hepatitis, and hepatic cancer.
- Cardiovascular arrest and shock.
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 |
|---|---|---|
| Atorvastatin calciumAlso: LipitorEligible patients will receive 80mgs of atorvastatin orally upon admission to hospital prior to percutaneous intervention of the affected artery. Dose of post-procedural statin will be at the discretion of the cardiologist. | Drug | Atorvastatin calcium |
| Inactive PlaceboAlso: Placebo, Sugar PillEligible patients will receive a placebo orally upon admission to hospital prior to percutaneous intervention of the affected artery. | Drug | Sugar Pill |
Primary outcome
Major adverse cardiovascular event (MACE) defined as cardiovascular death, MI, or target revascularization 30 days post percutaneous intervention.
Time frame: 15 and 30 days post revascularization
4 secondary outcomes
Any increase in mean peak values of CK-MB, troponin I and myoglobin greater than twice the upper limit after intervention.
Time frame: 15 and 30 days post revascularization
Any occurrence of major adverse cardiac events defined as death, MI, congestive heart failure, cardiogenic shock or need for unplanned revascularization within 24 hours after procedure or need for emergent CABG.
Time frame: 15 and 30 days post revascularization
Symptomatic side effects of current statin medication as described by adverse effects on consent form.
Time frame: Immediately post revascularization to 30 days.
Modified Coronary Revascularization Outcome Questionnaire (CROQ-PTCA)
Time frame: 15 and 30 days post revascularization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
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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.
Venkatraman Srinivasan, MD principal investigator
West Penn Allegheny Health System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin calcium in people with Acute Myocardial Infarction, run by The Western Pennsylvania Hospital at 2 sites in United States.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 5 Oct 2018. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Major adverse cardiovascular event (MACE) defined as cardiovascular death, MI, or target revascularization 30 days post percutaneous intervention. (time frame: 15 and 30 days post revascularization). 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 5 Oct 2018; AzTrials last refreshed its copy on 8 Nov 2026.