Coronary DiseasePhase 4NCT00344019
Effects of Atorvastatin on Myonecrosis
A Phase 4 study testing Atorvastatin 80mg and Screening in people with Coronary Disease, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This study is designed as a prospective, randomized, placebo-controlled, double-blind analysis of atorvastatin 80 mg versus placebo administered on average 4 hours prior to percutaneous coronary intervention [PCI] (at least 2 hours) in patients presenting with unstable angina. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Atorvastatin 80mg and Screening
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Jan 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be aged 18 or over.
- Patients must provide written informed consent.
- Patients are presenting with unstable angina (defined as new onset chest pain, accelerating chest pain, chest pain at rest and ST-segment depression on the electrocardiogram [EKG])
- Patients undergoing successful coronary stent implantation of the (presumed) culprit lesion (defined as < 50% residual stenosis).
Who cannot join
- Any patient who is unable to give written informed consent.
- Any condition which, in the investigator's opinion, would interfere with optimal participation in the study or produce a significant risk to the patient.
- Patients presenting with an ST-elevation myocardial infarction (MI).
- Patients with elevated troponin, CK, or CK-MB (above the upper limit of normal).
- Patients already on high-dose statin therapy (defined as any statin equivalent to atorvastatin ≥ 40 mg).
- Patients who took any statin agent within 24 hours of presentation to the cardiac catheterization laboratory.
Show all 10Show fewer
- Patients with active hepatic disease or myositis, in whom statin therapy is contraindicated.
- Patients with hypersensitivity to atorvastatin.
- Patients with procedural complications, including unsuccessful percutaneous transluminal coronary angioplasty (PTCA)/stenting, major side-branch occlusion, flow-limiting dissections at the completion of the procedure, emergent coronary artery bypass surgery, peri-procedural thrombus formation with distal embolization, stent thrombosis within the first 24 hours, repeat emergent PCI within 24 hours, and death within 24 hours.
- Cardiogenic shock.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Effects of Single-Dose Atorvastatin on Peri-Procedural Myonecrosis During Percutaneous Coronary Intervention in Patients With Acute Coronary Syndromes - The NO-MI Study
This study is designed as a prospective, randomized, placebo-controlled, double-blind analysis of atorvastatin 80 mg versus placebo administered on average 4 hours prior to percutaneous coronary intervention [PCI] (at least 2 hours) in patients presenting with unstable angina. Only patients with negative cardiac biomarkers, measured on 2 separate occasions a few hours apart will be eligible for inclusion. Furthermore, patients already on high-dose statin therapy; patients taking any statin within 24 hours prior to the PCI; and patients with contraindications to statins will be excluded from the study. The primary endpoint is a quantitative troponin level at 18-24 hours after PCI. At an enrollment of a total of 150 patients (75 per group), the study is powered to detect a 30% difference in troponin level. Secondary endpoints include elevation of creatine kinase (CK) and CK-MB above the upper limit of normal, change in C-reactive protein (CRP) levels from baseline and thrombolysis in myocardial infarction (TIMI) myocardial perfusion grade. All patients will be started on statin therapy the day after the procedure, as deemed appropriate by their treating physicians.
Read the detailed description
STUDY OBJECTIVES:
- The primary endpoint of the study is to evaluate the effects of a single high dose of atorvastatin versus placebo on peri-procedural myonecrosis, as measured by troponin T (TnT), during percutaneous coronary intervention (PCI) in patients presenting with acute coronary syndromes (ACS).
- Secondary endpoints include the measurements of other biomarkers of myocyte injury (CK, CK-MB) and inflammation (CRP).
- Other secondary endpoints include the relative angiographic efficacy of atorvastatin versus placebo on the post PCI growth of tissue level perfusion circumference and the post PCI growth of tissue level perfusion brightness using digital subtraction angiography.
METHODS:
- Selection and Number of Patients
The study subjects are to be selected from those patients presenting to the BIDMC for cardiac catheterization. Eligible patients will be identified in the cardiac catheterization holding area prior to their procedure. After obtaining informed consent, patients will be randomized to a single dose of atorvastatin or placebo, which will be administered in the holding area about 4 hours prior to the procedure. There will be a total of 150 subjects enrolled in the study. There are a total of 2500 PCIs performed at the BIDMC per year, a third of which are for ACS. We anticipate that 30-40% of patients with ACS will be eligible for study participation.
II. Informed Consent
Informed consent will be obtained from all individuals prior to enrolment in the study according to local Internal Review Board guidelines.
III. Pretreatment Data Collection
Baseline clinical data will be recorded at enrolment and will include: Subject's age, sex, weight and height, diabetes, hypertension, smoking status, hypercholesterolemia (including cholesterol levels if available), the presence of coronary or peripheral artery disease and prior history of PCI or coronary artery bypass surgery. Further, all current medications will be recorded. A detailed angina history will be collected from the patient and the medical record looking for evidence of unstable angina as defined by Braunwald.
IV. Medications
- Study Medication
Patients will be randomly assigned to atorvastatin 80 mg po or placebo in a double-blind fashion. The study medication will be administered immediately after informed consent is obtained and the patient is randomized to a treatment group in the cardiac catheterization holding area. Given the typical waiting time between first presentation in the holding area and PCI in a non-emergent case, it is estimated that the study medication will be administered 4 hours prior to the procedure (minimal time of 2 hours). All patients will receive a single dose of study medication prior to the procedure. After the completion of the procedure, all statin therapy will be withheld until the next day. Eligible patients can then receive statin therapy according to the treating physicians' preferences. All potential adverse reactions to the study medication will be recorded.
- Concomitant Therapy
Aspirin (325 mg/day) will be administered prior to intervention and during follow-up. Clopidogrel (300 mg or 600 mg bolus followed by 75 mg/day) will be administered post-stent deployment. It is expected that the majority of patients will receive a glycoprotein IIb/IIIa inhibitor during the procedure and for 18 hours thereafter.
- Procedures
- Laboratory Tests
At baseline, levels of troponin, CK and CK-MB will be obtained at the time of presentation and immediately prior to PCI. Patients with any of these serum markers above the upper limit of normal will be excluded from the study. Post-procedural enzymes will be obtained 6-8 hours after the procedure and the next morning (18-24 hours after the procedure). Patients with elevated enzymes may undergo further sampling to determine the peak enzyme rise. The peak troponin level obtained from any post-procedural blood draw will be used as the primary endpoint. Furthermore, baseline CRP levels will be obtained prior to PCI and on the next day.
- Digital Subtraction Angiography
To quantitate the kinetics of dye entry into the myocardium, digital subtraction angiography can be used. Digital subtraction angiography will be performed at end diastole by aligning cineframe images before dye filled the myocardium with the frame in which dye first reached its peak brightness. The spine, ribs, diaphragm and the epicardial artery are then subtracted. A representative region of the myocardium is sampled that is free of overlap by epicardial arterial branches to determine the increase in the gray scale brightness of the myocardium. The circumference of the myocardial blush is measured using a handheld planimeter (Fowler, Inc). The frame count ÷ number of frames per second is used to measure the time elapsed during angiography to quantitate the rate of rise in the growth (cm/sec) and brightness (gray/sec) of myocardial blush. Blush will also be assessed visually using the TIMI myocardial perfusion grade.
- Conditions
- Coronary Disease
- Being tested
- Placebo Oral Tablet, Atorvastatin 80mg, Screening
- Keywords
- Acute coronary syndrome, Percutaneous coronary intervention, Peri-procedure myocardial infarction
- Medical subject headings
- Coronary Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Oral TabletDrug
placebo pre-PCI for ACS
Atorvastatin 80mgDrug
Also called lipitor
atorvastatin 80 mg pre-angio/PCI
ScreeningOther
Patients signed consent to be screened for eligibility for randomization to placebo vs. study drug (atorvastatin)
| Study group | Role | What they receive |
|---|---|---|
| atorvastatin 80 mg | Active comparator | 80 mg atorvastatin on average of 2-4 hours pre angio/PCI for ACS Receives: Drug: Atorvastatin 80mg; Other: Screening |
| placebo oral tablet | Placebo comparator | placebo on average of 2-4 hours pre angio/PCI for ACS Receives: Drug: Placebo Oral Tablet; Other: Screening |
| Screening | No intervention | Patients signed consent if willing to participate. Patients will continue onto randomization if appropriate per inc/exc (i.e. stent placement) otherwise screen fail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-procedural Myonecrosis
As measured by troponin T (TnT), during percutaneous coronary intervention (PCI). TnT will be measured at 18-24 hours. Assuming a 40% event rate (elevation in TnT), this study powered to predict 30% relative reduction in TnT
Measured: 24 hours
Secondary outcomes (3)
Other Biomarkers of Myocyte Injury (CK, CK-MB)
No data was analyzed due to small numbers. Collected data no longer available as retention period has passed
Measured: 24 hours
Inflammatory Markers (CRP)
No data was analyzed due to small numbers. Collected data no longer available as retention period has passed
Measured: 24 hours
Post PCI Growth of Tissue Level Perfusion Circumference and Brightness Using Digital Subtraction Angiography
No data was analyzed due to small numbers. Collected data no longer available as retention period has passed
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2006 (estimated)
- Study startMay 2006
- Primary completionOct 2008
- Study completionJan 2009
Why it stopped: slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized trial of 80 mg atorvastatin vs. placebo pre PCI
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Joseph Carrozza, Jr, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344019
- Sponsor's protocol ID
- 2006P000035
- Status last verified
- Dec 2017
- First submitted
- 22 Jun 2006
- Last updated
- 2 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: no plans to share data
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Single-Dose Atorvastatin on Peri-Procedural Myonecrosis During Percutaneous Coronary Intervention in Patients With Acute Coronary Syndromes - The NO-MI Study
- ClinicalTrials.gov ID
- NCT00344019
- Acronym / sponsor ID
- 2006P000035
- Conditions
- Coronary Disease
- Keywords
- Acute coronary syndrome, Percutaneous coronary intervention, Peri-procedure myocardial infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- May 2006 (actual)
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 26 Jun 2006 (estimated)
- Results
- Posted 2 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed as a prospective, randomized, placebo-controlled, double-blind analysis of atorvastatin 80 mg versus placebo administered on average 4 hours prior to percutaneous coronary intervention [PCI] (at least 2 hours) in patients presenting with unstable angina. Only patients with negative cardiac biomarkers, measured on 2 separate occasions a few hours apart will be eligible for inclusion. Furthermore, patients already on high-dose statin therapy; patients taking any statin within 24 hours prior to the PCI; and patients with contraindications to statins will be excluded from the study. The primary endpoint is a quantitative troponin level at 18-24 hours after PCI. At an enrollment of a total of 150 patients (75 per group), the study is powered to detect a 30% difference in troponin level. Secondary endpoints include elevation of creatine kinase (CK) and CK-MB above the upper limit of normal, change in C-reactive protein (CRP) levels from baseline and thrombolysis in myocardial infarction (TIMI) myocardial perfusion grade. All patients will be started on statin therapy the day after the procedure, as deemed appropriate by their treating physicians.
Detailed description
STUDY OBJECTIVES:
- The primary endpoint of the study is to evaluate the effects of a single high dose of atorvastatin versus placebo on peri-procedural myonecrosis, as measured by troponin T (TnT), during percutaneous coronary intervention (PCI) in patients presenting with acute coronary syndromes (ACS).
- Secondary endpoints include the measurements of other biomarkers of myocyte injury (CK, CK-MB) and inflammation (CRP).
- Other secondary endpoints include the relative angiographic efficacy of atorvastatin versus placebo on the post PCI growth of tissue level perfusion circumference and the post PCI growth of tissue level perfusion brightness using digital subtraction angiography.
METHODS:
- Selection and Number of Patients
The study subjects are to be selected from those patients presenting to the BIDMC for cardiac catheterization. Eligible patients will be identified in the cardiac catheterization holding area prior to their procedure. After obtaining informed consent, patients will be randomized to a single dose of atorvastatin or placebo, which will be administered in the holding area about 4 hours prior to the procedure. There will be a total of 150 subjects enrolled in the study. There are a total of 2500 PCIs performed at the BIDMC per year, a third of which are for ACS. We anticipate that 30-40% of patients with ACS will be eligible for study participation.
II. Informed Consent
Informed consent will be obtained from all individuals prior to enrolment in the study according to local Internal Review Board guidelines.
III. Pretreatment Data Collection
Baseline clinical data will be recorded at enrolment and will include: Subject's age, sex, weight and height, diabetes, hypertension, smoking status, hypercholesterolemia (including cholesterol levels if available), the presence of coronary or peripheral artery disease and prior history of PCI or coronary artery bypass surgery. Further, all current medications will be recorded. A detailed angina history will be collected from the patient and the medical record looking for evidence of unstable angina as defined by Braunwald.
IV. Medications
- Study Medication
Patients will be randomly assigned to atorvastatin 80 mg po or placebo in a double-blind fashion. The study medication will be administered immediately after informed consent is obtained and the patient is randomized to a treatment group in the cardiac catheterization holding area. Given the typical waiting time between first presentation in the holding area and PCI in a non-emergent case, it is estimated that the study medication will be administered 4 hours prior to the procedure (minimal time of 2 hours). All patients will receive a single dose of study medication prior to the procedure. After the completion of the procedure, all statin therapy will be withheld until the next day. Eligible patients can then receive statin therapy according to the treating physicians' preferences. All potential adverse reactions to the study medication will be recorded.
- Concomitant Therapy
Aspirin (325 mg/day) will be administered prior to intervention and during follow-up. Clopidogrel (300 mg or 600 mg bolus followed by 75 mg/day) will be administered post-stent deployment. It is expected that the majority of patients will receive a glycoprotein IIb/IIIa inhibitor during the procedure and for 18 hours thereafter.
- Procedures
- Laboratory Tests
At baseline, levels of troponin, CK and CK-MB will be obtained at the time of presentation and immediately prior to PCI. Patients with any of these serum markers above the upper limit of normal will be excluded from the study. Post-procedural enzymes will be obtained 6-8 hours after the procedure and the next morning (18-24 hours after the procedure). Patients with elevated enzymes may undergo further sampling to determine the peak enzyme rise. The peak troponin level obtained from any post-procedural blood draw will be used as the primary endpoint. Furthermore, baseline CRP levels will be obtained prior to PCI and on the next day.
- Digital Subtraction Angiography
To quantitate the kinetics of dye entry into the myocardium, digital subtraction angiography can be used. Digital subtraction angiography will be performed at end diastole by aligning cineframe images before dye filled the myocardium with the frame in which dye first reached its peak brightness. The spine, ribs, diaphragm and the epicardial artery are then subtracted. A representative region of the myocardium is sampled that is free of overlap by epicardial arterial branches to determine the increase in the gray scale brightness of the myocardium. The circumference of the myocardial blush is measured using a handheld planimeter (Fowler, Inc). The frame count ÷ number of frames per second is used to measure the time elapsed during angiography to quantitate the rate of rise in the growth (cm/sec) and brightness (gray/sec) of myocardial blush. Blush will also be assessed visually using the TIMI myocardial perfusion grade.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- randomized trial of 80 mg atorvastatin vs. placebo pre PCI
| Arm | Type | Receives |
|---|---|---|
| atorvastatin 80 mg | Active comparator | Drug: Atorvastatin 80mg, Other: Screening80 mg atorvastatin on average of 2-4 hours pre angio/PCI for ACS |
| placebo oral tablet | Placebo comparator | Drug: Placebo Oral Tablet, Other: Screeningplacebo on average of 2-4 hours pre angio/PCI for ACS |
| Screening | No intervention | –Patients signed consent if willing to participate. Patients will continue onto randomization if appropriate per inc/exc (i.e. stent placement) otherwise screen fail |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must be aged 18 or over.
- Patients must provide written informed consent.
- Patients are presenting with unstable angina (defined as new onset chest pain, accelerating chest pain, chest pain at rest and ST-segment depression on the electrocardiogram [EKG])
- Patients undergoing successful coronary stent implantation of the (presumed) culprit lesion (defined as < 50% residual stenosis).
Key exclusion criteria (10 listed)
- Any patient who is unable to give written informed consent.
- Any condition which, in the investigator's opinion, would interfere with optimal participation in the study or produce a significant risk to the patient.
- Patients presenting with an ST-elevation myocardial infarction (MI).
- Patients with elevated troponin, CK, or CK-MB (above the upper limit of normal).
- Patients already on high-dose statin therapy (defined as any statin equivalent to atorvastatin ≥ 40 mg).
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 |
|---|---|---|
| Placebo Oral Tabletplacebo pre-PCI for ACS | Drug | placebo oral tablet |
| Atorvastatin 80mgAlso: lipitoratorvastatin 80 mg pre-angio/PCI | Drug | atorvastatin 80 mg |
| ScreeningPatients signed consent to be screened for eligibility for randomization to placebo vs. study drug (atorvastatin) | Other | atorvastatin 80 mg, placebo oral tablet |
Primary outcome
Peri-procedural Myonecrosis
Time frame: 24 hours
As measured by troponin T (TnT), during percutaneous coronary intervention (PCI). TnT will be measured at 18-24 hours. Assuming a 40% event rate (elevation in TnT), this study powered to predict 30% relative reduction in TnT
3 secondary outcomes
Other Biomarkers of Myocyte Injury (CK, CK-MB)
Time frame: 24 hours
Inflammatory Markers (CRP)
Time frame: 24 hours
Post PCI Growth of Tissue Level Perfusion Circumference and Brightness Using Digital Subtraction Angiography
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. no plans to share data
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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.
Joseph Carrozza, Jr, MD principal investigator
Beth Israel Deaconess Medical Center
1 site 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 80mg and Screening in people with Coronary Disease, run by Beth Israel Deaconess Medical Center at 1 site 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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 2 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 2 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Peri-procedural Myonecrosis (time frame: 24 hours). 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 2 Jan 2018; AzTrials last refreshed its copy on 7 Nov 2026.