Chronic Renal FailurePhase 4NCT01103336
Preventive Effect of the PRetreatment With Intravenous Nicorandil on Contrast-Induced Nephropathy in Patients With RenaL Dysfunction UndEergoing Coronary Angiography (PRINCIPLE Study)
A Phase 4 study of Chronic Renal Failure, run by Yonsei University at 1 site in South Korea.
Trial summary
Renal hypoxia plays an important role in the development of contrast-induced nephropathy. The purpose of the PRINCIPLE study is to investigate the effect of pretreatment with intravenous nicorandil on the incidence of contrast-induced nephropathy in patients with renal insufficiency undergoing coronary angiography. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Renal Failure
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 173 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2010to Jun 2011
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥ 20 years
- Patients undergoing elective coronary angiogram due to documented myocardial ischemia or symptoms of angina
- Estimated Cr clearance ≤60 mL/min by Cockcroft-Gault formula or serum Cr ≥1.1 mg/dL
- Signed written informed consent to participate in the study
Who cannot join
- Acute myocardial infarction requiring primary or rescue coronary intervention
- Allergic reaction to contrast dye or nicorandil
- Cardiogenic shock or significant hypotension
- Previous use of nicorandil within the preceding 7 days
- Exposure to contrast medium within the preceding 7 days
- Pregnancy or women at age of childbearing potential
Show all 14Show fewer
- Heart failure (NYHA class III or IV; LV ejection fraction <40% by echocardiogram)
- Acute renal failure or chronic dialysis
- Mechanical ventilation
- History of kidney transplantation
- Life expectation less than 6 months
- Previous renal artery angioplasty within the last 6 months
- Use of nonsteroidal anti-inflammatory drugs, intravenous use of diuretics, dopamine, mannitol, N-acetylcysteine, ascorbic acid or sodium bicarbonate within 48 hrs before the procedure
- Severe liver disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventive Effect of the PRetreatment With Intravenous Nicorandil on Contrast-Induced Nephropathy in Patients With RenaL Dysfunction UndEergoing Coronary Angiography (PRINCIPLE Study): A Investigator-initiated, Control- Randomized, Phase IV Multicenter Study
Renal hypoxia plays an important role in the development of contrast-induced nephropathy. The purpose of the PRINCIPLE study is to investigate the effect of pretreatment with intravenous nicorandil on the incidence of contrast-induced nephropathy in patients with renal insufficiency undergoing coronary angiography.
- Conditions
- Chronic Renal Failure
- Being tested
- pretreatment with intravenous nicorandil vs. placebo before coronary angiography
- Keywords
- Patients with chronic renal failure undergoing coronary angiography
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pretreatment with intravenous nicorandil vs. placebo before coronary angiographyDrug
Also called Nicorandil group versus Control group
- Nicorandil group: Pretreatment with intravenous Nicorandil (Sigmart for injection, Choongwae Pharma, Seoul) 12 mg in 0.9% saline 100 ml over 2 hours starting from 1 hour prior to coronary angiography
- Control group: Pretreatment with intravenous 0.9% saline 100 ml over 2 hours starting from 1 hour prior to coronary angiography
| Study group | Role | What they receive |
|---|---|---|
| Nicorandil in saline | Experimental | Not described Receives: Drug: pretreatment with intravenous nicorandil vs. placebo before coronary angiography |
| saline | Placebo comparator | Not described Receives: Drug: pretreatment with intravenous nicorandil vs. placebo before coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of contrast-induced nephropathy defined as an increase in serum creatinine ≥25% or ≥0.5 mg/dl
Measured: at 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- More trials run by Yonsei 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
- Investigators
- Young-Guk Ko, MD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103336
- Sponsor's protocol ID
- 4-2009-0722
- Status last verified
- Feb 2012
- First submitted
- 8 Apr 2010
- Last updated
- 6 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Effect of the PRetreatment With Intravenous Nicorandil on Contrast-Induced Nephropathy in Patients With RenaL Dysfunction UndEergoing Coronary Angiography (PRINCIPLE Study): A Investigator-initiated, Control- Randomized, Phase IV Multicenter Study
- ClinicalTrials.gov ID
- NCT01103336
- Acronym / sponsor ID
- 4-2009-0722
- Conditions
- Chronic Renal Failure
- Keywords
- Patients with chronic renal failure undergoing coronary angiography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- Mar 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 14 Apr 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.
Renal hypoxia plays an important role in the development of contrast-induced nephropathy. The purpose of the PRINCIPLE study is to investigate the effect of pretreatment with intravenous nicorandil on the incidence of contrast-induced nephropathy in patients with renal insufficiency undergoing coronary angiography.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicorandil in saline | Experimental | Drug: pretreatment with intravenous nicorandil vs. placebo before coronary angiography |
| saline | Placebo comparator | Drug: pretreatment with intravenous nicorandil vs. placebo before coronary angiography |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged ≥ 20 years
- Patients undergoing elective coronary angiogram due to documented myocardial ischemia or symptoms of angina
- Estimated Cr clearance ≤60 mL/min by Cockcroft-Gault formula or serum Cr ≥1.1 mg/dL
- Signed written informed consent to participate in the study
Key exclusion criteria (14 listed)
- Acute myocardial infarction requiring primary or rescue coronary intervention
- Allergic reaction to contrast dye or nicorandil
- Cardiogenic shock or significant hypotension
- Previous use of nicorandil within the preceding 7 days
- Exposure to contrast medium within the preceding 7 days
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 |
|---|---|---|
| pretreatment with intravenous nicorandil vs. placebo before coronary angiographyAlso: Nicorandil group versus Control group* Nicorandil group: Pretreatment with intravenous Nicorandil (Sigmart for injection, Choongwae Pharma, Seoul) 12 mg in 0.9% saline 100 ml over 2 hours starting from 1 hour prior to coronary angiography * Control group: Pretreatment with intravenous 0.9% saline 100 ml over 2 hours starting from 1 hour prior to coronary angiography | Drug | Nicorandil in saline, saline |
Primary outcome
Incidence of contrast-induced nephropathy defined as an increase in serum creatinine ≥25% or ≥0.5 mg/dl
Time frame: at 24 hours
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 6 Feb 2012.
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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.
Young-Guk Ko, MD principal investigator
Severance Hospital
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 of Chronic Renal Failure, run by Yonsei University 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 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: finished, as of the sponsor's last update on 6 Feb 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. 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?
Incidence of contrast-induced nephropathy defined as an increase in serum creatinine ≥25% or ≥0.5 mg/dl (time frame: at 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 6 Feb 2012.