Coronary Artery DiseaseESTATENCT00979940
Effects of Short Term, High Dose Atorvastatin Therapy on Periprocedural Myonecrosis and Platelet Inhibition After Percutaneous Coronary Intervention (PCI)
A study testing Atorvastatin in people with Coronary Artery Disease, run by Indiana University at 2 sites in United States.
Trial summary
This research study plans to evaluate the use of atorvastatin in patients with coronary artery disease given immediately before PCI and whether it will decrease the amount of heart damage after PCI. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2008to Aug 2014
- Phase
- Interventional
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing revascularization for significant coronary artery disease
- age range 21-85 years
Who cannot join
- non-STEMI, STEMI
- cancer
- renal failure with creatinine>3.0mg/dl
- liver cirrhosis
- lymphoproliferative disorder
- pregnancy
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- thrombocytopenia<150'000
- coagulopathy (INR>1.5)
- abnormal liver function tests
- illicit drug use
- history of statin intolerance
- history of rhabdomyolysis
- planned use of Glycoprotein IIb/IIIa inhibitors during PCI
- current therapy with atorvastatin, pravastatin, lovastatin, fluvastatin, or rosuvastatin
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Methodist Hospital
Indianapolis, Indiana, 46202
Wishard Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Effects of Short Term, High Dose Atorvastatin Therapy on Periprocedural Myonecrosis and Platelet Inhibition After PCI
This research study plans to evaluate the use of atorvastatin in patients with coronary artery disease given immediately before PCI and whether it will decrease the amount of heart damage after PCI.
- Conditions
- Coronary Artery Disease
- Being tested
- Atorvastatin
- Keywords
- atorvastatin, clopidogrel, percutaneous intervention, periprocedural myonecrosis
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Atorvastatin 80mg po given one time before PCI in cath lab.
| Study group | Role | What they receive |
|---|---|---|
| No atorvastatin | No intervention | Patients do not receive Atorvastatin prior to PCI in cath lab |
| atorvastatin | Experimental | Atorvastatin 80mg po given prior to PCI in cath lab Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periprocedural Myonecrosis
Measured: 16-24 hours post PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study startNov 2008
- Primary completionJun 2014
- Study completionAug 2014
Why it stopped: Slower than anticipated enrollment for pilot study.
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Responsible party
- Sponsor
- Investigators
- Rolf Kreutz, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979940
- Sponsor's protocol ID
- 0712-15
- Other IDs
- 1470
- Acronym
- ESTATE
- Status last verified
- Aug 2015
- First submitted
- 17 Sep 2009
- Last updated
- 22 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kreutz RP, Breall JA, Sinha A, von der Lohe E, Kovacs RJ, Flockhart DA. Simultaneous administration of high-dose atorvastatin and clopidogrel does not interfere with platelet inhibition during percutaneous coronary intervention. Clin Pharmacol. 2016 Jun 3;8:45-50. doi: 10.2147/CPAA.S98790. eCollection 2016.
PubMed 27350760
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Short Term, High Dose Atorvastatin Therapy on Periprocedural Myonecrosis and Platelet Inhibition After PCI
- ClinicalTrials.gov ID
- NCT00979940
- Acronym / sponsor ID
- ESTATE / 0712-15
- Conditions
- Coronary Artery Disease
- Keywords
- atorvastatin, clopidogrel, percutaneous intervention, periprocedural myonecrosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slower than anticipated enrollment for pilot study.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Nov 2008
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 18 Sep 2009 (estimated)
- Results
- Posted 22 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study plans to evaluate the use of atorvastatin in patients with coronary artery disease given immediately before PCI and whether it will decrease the amount of heart damage after PCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No atorvastatin | No intervention | –Patients do not receive Atorvastatin prior to PCI in cath lab |
| atorvastatin | Experimental | Drug: AtorvastatinAtorvastatin 80mg po given prior to PCI in cath lab |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients undergoing revascularization for significant coronary artery disease
- age range 21-85 years
Key exclusion criteria (14 listed)
- non-STEMI, STEMI
- cancer
- renal failure with creatinine>3.0mg/dl
- liver cirrhosis
- lymphoproliferative disorder
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 |
|---|---|---|
| AtorvastatinAtorvastatin 80mg po given one time before PCI in cath lab. | Drug | atorvastatin |
Primary outcome
Periprocedural Myonecrosis
Time frame: 16-24 hours post PCI
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27350760Kreutz RP, Breall JA, Sinha A, von der Lohe E, Kovacs RJ, Flockhart DA. Simultaneous administration of high-dose atorvastatin and clopidogrel does not interfere with platelet inhibition during percutaneous coronary intervention. Clin Pharmacol. 2016 Jun 3;8:45-50. doi: 10.2147/CPAA.S98790. eCollection 2016.
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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.
Rolf Kreutz, MD principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atorvastatin in people with Coronary Artery Disease, run by Indiana University 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 14 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 22 Sep 2015. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2015). 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?
Periprocedural Myonecrosis (time frame: 16-24 hours post PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00979940, which also lists 1 linked publication.
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 22 Sep 2015.