Percutaneous Coronary InterventionPhase 4NCT00786734
Pitavastatin Pre-Treatment Study in Patient With Elective PCI for Stable Angina Pectoris (PIPA)
A Phase 4 study testing Pitavastatin in people with Percutaneous Coronary Intervention, run by JW Pharmaceutical at 1 site in South Korea.
Trial summary
Patients who is scheduled elective PCI are randomized to pitavastatin 4mg daily or without pitavastatin for 5 -7days before the procedure. Creatine kinase-MB, troponin I, and myoglobin levels are measured at baseline and at 8 and 24 hours after the procedure(1st evaluation). Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Percutaneous Coronary Intervention
- What is being tested?
- Pitavastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2008to Jul 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with LDL ≥ 100mg/dL
- Patients who are scheduled an elective PCI for stable angina
Who cannot join
- Acute myocardial infarction (<3 months)
- Unstable angina
- Previous treatment with statins (<6 months)
- Increase in CK-MB above upper normal limit
- Increase in liver enzymes (AST/ALT) above 2 times of upper normal limit
- Increase in serum creatinine above 2 times of upper normal limit
- Left ventricular ejection fraction <30%
- Previous treatment with glycoprotein Ⅱb/Ⅲa receptor inhibitor (<4 weeks)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Catholic University of Korea Kangnam St. Mary's Hospital
Seoul
About this study
Official title: A Randomized, Open Label, Comparative Study to Evaluate Effect of Pitavastatin for Reduction of Myocardial Damage in Patient Are Scheduled Elective PCI for Stable Angina Pectoris
Patients who is scheduled elective PCI are randomized to pitavastatin 4mg daily or without pitavastatin for 5 -7days before the procedure. Creatine kinase-MB, troponin I, and myoglobin levels are measured at baseline and at 8 and 24 hours after the procedure(1st evaluation). After PCI, pitavastatin will be administered for additional 4 weeks(2nd evaluation).
Read the detailed description
Procedural ischemic myocardial injury remains the most frequent complication after coronary angioplasty. Recently it was reported that pretreatment with atorvastatin reduce the myocardial damage compared to placebo. Thus, we will evaluate the difference of pretreatment of pitavastatin compared to standard therapy on the reduction of myocardial damage in patient who is scheduled elective PCI for stable angina pectoris.
- Conditions
- Percutaneous Coronary Intervention
- Being tested
- Pitavastatin
- Keywords
- pitavastatin, PCI, stable angina
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PitavastatinDrug
4mg daily for 5-7 days before Percutaneous Coronary Intervention(PCI) and 4mg daily for 28 days after PCI
PitavastatinDrug
4mg daily for 28 days after PCI
| Study group | Role | What they receive |
|---|---|---|
| Pitavastatin Group | Experimental | Not described Receives: Drug: Pitavastatin |
| Usual Care Group | Other | Not described Receives: Drug: Pitavastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients whose CK-MB > 2 times above UNL
Measured: First evaulation time (before PCI)
Secondary outcomes (4)
Proportion of patients who show any increase of CK-MB, troponin I, and myoglobin above UNL
Measured: First evaluation time
Mean peak values of CK-MB, troponin I and myoglobin after intervention
Measured: After PCI (<24hrs)
Change of hs-CRP, wall motion score
Measured: Second evaluation time
Occurence of all major adverse cardiac events
Measured: Second evaluation time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startAug 2008
- Primary completionMay 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ki Bae Seung, Ph.D, Principal investigator, Professor, Catholic University of Korea Kangnam St. Mary's Hospital located
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786734
- Sponsor's protocol ID
- CWP-PTV-705
- Status last verified
- Mar 2012
- First submitted
- 5 Nov 2008
- Last updated
- 30 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Comparative Study to Evaluate Effect of Pitavastatin for Reduction of Myocardial Damage in Patient Are Scheduled Elective PCI for Stable Angina Pectoris
- ClinicalTrials.gov ID
- NCT00786734
- Acronym / sponsor ID
- CWP-PTV-705
- Conditions
- Percutaneous Coronary Intervention
- Keywords
- pitavastatin, PCI, stable angina
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 6 Nov 2008 (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 who is scheduled elective PCI are randomized to pitavastatin 4mg daily or without pitavastatin for 5 -7days before the procedure. Creatine kinase-MB, troponin I, and myoglobin levels are measured at baseline and at 8 and 24 hours after the procedure(1st evaluation). After PCI, pitavastatin will be administered for additional 4 weeks(2nd evaluation).
Detailed description
Procedural ischemic myocardial injury remains the most frequent complication after coronary angioplasty. Recently it was reported that pretreatment with atorvastatin reduce the myocardial damage compared to placebo. Thus, we will evaluate the difference of pretreatment of pitavastatin compared to standard therapy on the reduction of myocardial damage in patient who is scheduled elective PCI for stable angina pectoris.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pitavastatin Group | Experimental | Drug: Pitavastatin |
| Usual Care Group | Other | Drug: Pitavastatin |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with LDL ≥ 100mg/dL
- Patients who are scheduled an elective PCI for stable angina
Key exclusion criteria (8 listed)
- Acute myocardial infarction (<3 months)
- Unstable angina
- Previous treatment with statins (<6 months)
- Increase in CK-MB above upper normal limit
- Increase in liver enzymes (AST/ALT) above 2 times of upper normal limit
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 |
|---|---|---|
| Pitavastatin4mg daily for 5-7 days before Percutaneous Coronary Intervention(PCI) and 4mg daily for 28 days after PCI | Drug | Pitavastatin Group |
| Pitavastatin4mg daily for 28 days after PCI | Drug | Usual Care Group |
Primary outcome
Proportion of patients whose CK-MB > 2 times above UNL
Time frame: First evaulation time (before PCI)
4 secondary outcomes
Proportion of patients who show any increase of CK-MB, troponin I, and myoglobin above UNL
Time frame: First evaluation time
Mean peak values of CK-MB, troponin I and myoglobin after intervention
Time frame: After PCI (<24hrs)
Change of hs-CRP, wall motion score
Time frame: Second evaluation time
Occurence of all major adverse cardiac events
Time frame: Second evaluation time
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2012.
Related trials for Percutaneous Coronary Intervention
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Hs-CRP-Guided Colchicine Treatment Targets in Very-High-Risk Patients With Coronary Artery Disease After PCI (TARGET-CHD)
Coronary Artery Disease, Atherosclerotic Cardiovascular Disease (ASCVD)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Not yet recruiting
ADVA ACE Coronary Stent System in Coronary Artery Disease Patients (ADVANCE)
Coronary Artery Disease, De Novo Stenosis Lesion
Recruiting
Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions
Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors
RecruitingPhase 3
Safety and Efficacy of Very Short DAPT in Older Patients Undergoing PCI
Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
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.
Ki Bae Seung, Ph.D principal investigator
Professor, Catholic University of Korea Kangnam St. Mary's Hospital located
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 Pitavastatin in people with Percutaneous Coronary Intervention, run by JW Pharmaceutical at 1 site in South Korea.
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 8 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: withdrawn, as of the sponsor's last update on 30 Mar 2012. 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 South Korea. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Proportion of patients whose CK-MB > 2 times above UNL (time frame: First evaulation time (before PCI)). 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 30 Mar 2012.