Coronary Artery DiseasePhase 4CLEAR-PCINCT01968577
Randomized Trial of Creatine-kinase Leak After Rosuvastatin At the Time of Percutaneous Coronary Intervention
A Phase 4 study testing Rosuvastatin in people with Coronary Artery Disease, run by Kleber Bomfim Araujo Martins at 1 site in Brazil.
Trial summary
Patients with stable coronary disease when undergoing percutaneous coronary intervention may present periprocedural myocardial infarction defined at present as a creatine kinase-myocardial isoenzyme (CK-MB) elevation 3 times upper limit of normal, as a cut off for periprocedural myocardial infarction after PCI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 528 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2011to Dec 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinical signs of stable angina (Classification of Canadian Cardiovascular Society 1, 2, 3 or 4) or asymptomatic with evidence of ischemia-induced functional tests with indication of elective PCI.
- Use of statins for a period equal to or greater than 7 days or reported by the patient and confirmed by medical prescription.
- Stent implantation in de novo lesions in native coronary arteries were considered eligible for the study
- The patient or legal representative must sign the consent form before the procedure, in form containing all the details of the research approved by the Ethics Committee of the Institution.
Who cannot join
- Women of childbearing potential who are not using appropriate contraceptive measures during pregnancy and lactation .
- Values above the upper limit of normal serum levels of CK-MB mass harvested 24 hours prior to the procedure.
- Myocardial infarction < 15 days.
- Renal insufficiency with creatinine clearance < 30 ml/min
- Patients with known allergy, hypersensitivity or contraindication to any of the following: aspirin , heparin , clopidogrel , ticagrelor , and statin or iodinated contrast .
- Participation in other research to influence serum levels of CK-MB mass
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- Have taken fibrate 24 hours before the intervention .
- Use of oral anticoagulants or glycoprotein inhibitors at the day of the procedure .
- Evidence of angiographic intracoronary thrombus in the target lesion .
- In -stent restenosis , vein graft or arterial .
- Complications of the procedure as irreversible occlusion of the target vessel as well as branch greater than 1mm in diameter , presence of dissection with compromised flow, caging branch with reduced flow , coronary spasm with abnormal blood flow and distal embolization .
- Inability to deploy stent .
- Use of atherectomy technique .
- Patients were randomized to rosuvastatin be administered prior to the procedure , having the guidewire stent reached the ostium of the coronary target with time less than two hours or having exceeded the period of six hours after oral ingestion.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo, 04012-180
AMANDA S GUERRA, DIRECTOR, 55-11-5085-6000, diretoriageral@dantepazzanese.org.br
KLEBER B A MARTINS, MD
About this study
Patients with stable coronary disease when undergoing percutaneous coronary intervention may present periprocedural myocardial infarction defined at present as a creatine kinase-myocardial isoenzyme (CK-MB) elevation 3 times upper limit of normal, as a cut off for periprocedural myocardial infarction after PCI. Although percutaneous coronary intervention is associated with low rates of complications, periprocedural myocardial infarction has been touted as a negative factor in long-term clinical results . Several clinical, anatomical and technical associate to the occurrence of this event . Although randomized controlled trials and systematic reviews to statin pre intervention have targeted the administration of high-dose statin is recommended before surgery to reduce the risk of periprocedural myocardial infarction, there is no information on the impact of the maximum concentration plasma of statin at the time of percutaneous coronary intervention in stable patients on chronic statin use in preventing periprocedural myocardial infarction or the elevation of cardiac enzymes . The anti-ischemic effect of statins in percutaneous coronary intervention was mainly determined in statin -naïve patients or in patients with acute coronary syndromes . In this work , we studied the impact of the peak plasma concentration of statin at the time of percutaneous coronary intervention was studied through prospective randomized single center in stable patients with chronic statin divided into two groups . In the group (1) Experimental (n = 268 ) was administered at a dose of 40 mg rosuvastatin between one and six hours before surgery and group (2) control without rosuvastatin (n = 268). This range 1 to 6 hours is the time at the peak concentration of rosuvastatin in the blood after oral ingestion. The primary objective was to assess the incidence of periprocedural myocardial infarction by creatine kinase above three times upper normal limit in hospital period and as a secondary objective to analyze the elevation of any amount of creatine kinase on the baseline.
- Conditions
- Coronary Artery Disease
- Being tested
- Rosuvastatin
- Keywords
- Coronary angioplasty, Myocardial infarction
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
Rosuvastatin 40 mg before percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin 40 mg | Experimental | Administration of rosuvastatin 40 mg 2 to 6 hours before percutaneous coronary intervention Receives: Drug: Rosuvastatin |
| Control group | No intervention | The group of patients that do not receive rosuvastatin, 40 mg, before percutaneous coronary intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periprocedural myocardial infarction (Myocardial enzymes arise)
Myocardial enzyme arise 3 times of upper limit of normal, 12 hours of the percutaneous coronary intervention until peak value at hospital discharge.
Measured: After 12 hours to hospital discharge
Secondary outcomes (1)
Any creatine kinase elevation
Any myocardial enzyme arise after 12 hours of the percutaneous coronary intervention until peak value at hospital discharge.
Measured: After 12 hours to hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study startMar 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- None (open label)
- Enrolment
- 528 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kleber Bomfim Araujo Martins
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kleber Bomfim Araujo Martins, University of Sao Paulo
- Investigators
- Kleber B A Martins, MD, Principal investigator, Instituto Dante Pazzanese e Cardiologia e Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968577
- Sponsor's protocol ID
- KBAM-120758
- Acronym
- CLEAR-PCI
- Status last verified
- Oct 2013
- First submitted
- 19 Oct 2013
- Last updated
- 24 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Creatine-kinase Leak After Rosuvastatin At the Time of Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT01968577
- Acronym / sponsor ID
- CLEAR-PCI / KBAM-120758
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary angioplasty, Myocardial infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 528 participants (estimated)
- Lead sponsor
- Kleber Bomfim Araujo MartinsUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 24 Oct 2013 (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.
Patients with stable coronary disease when undergoing percutaneous coronary intervention may present periprocedural myocardial infarction defined at present as a creatine kinase-myocardial isoenzyme (CK-MB) elevation 3 times upper limit of normal, as a cut off for periprocedural myocardial infarction after PCI. Although percutaneous coronary intervention is associated with low rates of complications, periprocedural myocardial infarction has been touted as a negative factor in long-term clinical results . Several clinical, anatomical and technical associate to the occurrence of this event . Although randomized controlled trials and systematic reviews to statin pre intervention have targeted the administration of high-dose statin is recommended before surgery to reduce the risk of periprocedural myocardial infarction, there is no information on the impact of the maximum concentration plasma of statin at the time of percutaneous coronary intervention in stable patients on chronic statin use in preventing periprocedural myocardial infarction or the elevation of cardiac enzymes . The anti-ischemic effect of statins in percutaneous coronary intervention was mainly determined in statin -naïve patients or in patients with acute coronary syndromes . In this work , we studied the impact of the peak plasma concentration of statin at the time of percutaneous coronary intervention was studied through prospective randomized single center in stable patients with chronic statin divided into two groups . In the group (1) Experimental (n = 268 ) was administered at a dose of 40 mg rosuvastatin between one and six hours before surgery and group (2) control without rosuvastatin (n = 268). This range 1 to 6 hours is the time at the peak concentration of rosuvastatin in the blood after oral ingestion. The primary objective was to assess the incidence of periprocedural myocardial infarction by creatine kinase above three times upper normal limit in hospital period and as a secondary objective to analyze the elevation of any amount of creatine kinase on the baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin 40 mg | Experimental | Drug: RosuvastatinAdministration of rosuvastatin 40 mg 2 to 6 hours before percutaneous coronary intervention |
| Control group | No intervention | –The group of patients that do not receive rosuvastatin, 40 mg, before percutaneous coronary intervention. |
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 with clinical signs of stable angina (Classification of Canadian Cardiovascular Society 1, 2, 3 or 4) or asymptomatic with evidence of ischemia-induced functional tests with indication of elective PCI.
- Use of statins for a period equal to or greater than 7 days or reported by the patient and confirmed by medical prescription.
- Stent implantation in de novo lesions in native coronary arteries were considered eligible for the study
- The patient or legal representative must sign the consent form before the procedure, in form containing all the details of the research approved by the Ethics Committee of the Institution.
Key exclusion criteria (14 listed)
- Women of childbearing potential who are not using appropriate contraceptive measures during pregnancy and lactation .
- Values above the upper limit of normal serum levels of CK-MB mass harvested 24 hours prior to the procedure.
- Myocardial infarction < 15 days.
- Renal insufficiency with creatinine clearance < 30 ml/min
- Patients with known allergy, hypersensitivity or contraindication to any of the following: aspirin , heparin , clopidogrel , ticagrelor , and statin or iodinated contrast .
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 |
|---|---|---|
| RosuvastatinAlso: CrestorRosuvastatin 40 mg before percutaneous coronary intervention | Drug | Rosuvastatin 40 mg |
Primary outcome
Periprocedural myocardial infarction (Myocardial enzymes arise)
Time frame: After 12 hours to hospital discharge
Myocardial enzyme arise 3 times of upper limit of normal, 12 hours of the percutaneous coronary intervention until peak value at hospital discharge.
1 secondary outcome
Any creatine kinase elevation
Time frame: After 12 hours to hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2013.
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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.
Kleber B A Martins, MD principal investigator
Instituto Dante Pazzanese e Cardiologia e Sao Paulo
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 Rosuvastatin in people with Coronary Artery Disease, run by Kleber Bomfim Araujo Martins at 1 site in Brazil.
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 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: status not confirmed, as of the sponsor's last update on 24 Oct 2013. 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 Brazil. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keber B A Martins, MD (55 79 8102-9611, klebermartins@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periprocedural myocardial infarction (Myocardial enzymes arise) (time frame: After 12 hours to hospital discharge). 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 24 Oct 2013.