Coronary Artery DiseasePhase 3NCT03755700
Vitamin E and N-acetylcysteine for Preventing Contrast-Induced Acute Kidney Injury After Coronary Artery Catheterization
A Phase 3 study testing Vitamin E, N-acetyl cysteine and Normal Saline Flush, 0.9% Injectable Solution in people with Coronary Artery Disease and Coronary Artery Angiography, run by Rajaie Cardiovascular Medical and Research Center at 1 site in Iran.
Trial summary
In a double-blinded randomized clinical trial, all patients undergoing coronary artery catheterization who will met our criteria, will be enrolled into three groups to receive either, vitamin e, n-acetylcysteine, or placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Angiography, Coronary Catheterization
- What is being tested?
- Vitamin E, N-acetyl cysteine and Normal Saline Flush, 0.9% Injectable Solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 siteIran
- Study dates
- 1 Nov 2018to 31 Dec 2019
- Phase
- Phase 3
- 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 aged ≥18 years with baseline estimated glomerular filtration rate (eGFR) <60 mL/min per 1.73 m2 (based on the Modification of Diet in Renal Disease study group formula) who undergo coronary catheterization (i.e. coronary angiography and percutaneous coronary intervention [PCI]) will be invited to the study if they meet the inclusion criteria: stable angina with ischemia and indication for coronary angiography, non-ST-segment elevation (NSTE) acute coronary syndrome (ACS) requiring an early invasive strategy, and patients undergoing elective PCI .
Who cannot join
- acute ST-segment elevation myocardial infarction, high-risk NSTE-ACS warranting emergency coronary angiography (<2 hours), cardiogenic shock, pulmonary edema, overt heart failure and/or ejection fraction <30%, ACS undergoing coronary angiography or angioplasty during the previous 5 days, sensitivity to contrast medium, recent administration of contrast medium for any reason, AKI, history of dialysis, pregnancy, newly prescribed angiotensin converting enzyme inhibitors or angiotensin receptor blockers, bleeding and/or coagulopathy diseases, and consumption of nephrotoxic drugs, vitamin E, vitamin C, or N-acetylcysteine (NAC) at least 48 hours before intervention.
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Rajaie cardiovascular medical and research center
Tehran, 1995614331
Majid Maleki, MD, +98 21 2392 ext. 2043, research@rhc.ac.ir
About this study
Official title: Antioxidants for Preventing Contrast-Induced Acute Kidney Injury After Coronary Artery Catheterization
In a double-blinded randomized clinical trial, all patients undergoing coronary artery catheterization who will met our criteria, will be enrolled into three groups to receive either, vitamin e, n-acetylcysteine, or placebo. The aim of study will be to compare the superiority of vitamin e over n-acetylcysteine for the prevention of contrast-induced acute kidney injury (CIAKI).
Read the detailed description
Patients aged ≥18 years with chronic kidney disease who undergo coronary catheterization will be enrolled into the study if they meet the inclusion criteria. Patients will be randomly assigned into three groups in a 1:1:1 ratio (Computer-generated random number will be used to assign a patient in either group): we will use simple randomization for assigning each patient in a group. The participants, physicians and outcome assessors will be blinded throughout the trial until the opening of the randomization cold.
All patients will be entered into three group and they will be given normal saline 0.9%, vitamin E, NAC, and the placebos of both regimens. The vitamin E will be given as a soft gel capsule and its placebo will have the same shape and taste. The NAC will be given as an effervescent tablet with a glass of water for consumption and its placebo will also have the same shape and taste. These drugs will be given in addition to the routine hydration therapy which will be given to all patients.
Primary outcome will be the development of CIAKI. Secondary outcomes will be the development of major adverse cardiovascular events and any events till evaluating the CIAKI within 48-72 hours after intervention.
- Conditions
- Coronary Artery Disease, Coronary Artery Angiography, Coronary Catheterization, Contrast-induced Nephropathy, Stable Angina, Acute Coronary Syndrome
- Being tested
- Vitamin E, N-acetyl cysteine, Placebo oral capsule, Placebos, Normal Saline Flush, 0.9% Injectable Solution
- Medical subject headings
- Coronary Artery Disease, Angina, Stable, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin EDrug
As a gel capsule of vitamin E 800 IU orally 2 hours before intervention and 400 IU orally 4 hours after intervention
N-acetyl cysteineDrug
As an effervescent tablets of NAC 1200 mg orally 2 hours before intervention and 1200 mg orally 4 hours after intervention
Placebo oral capsuleDrug
The placebo of vitamin E as a soft gel capsule with the consumption order similar to vitamin e group
PlacebosDrug
The placebo of n-acetylcysteine as a tablet with the consumption order similar to n-acetylcysteine group
Normal Saline Flush, 0.9% Injectable SolutionDrug
Normal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Normal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization combined with the placebos of both vitamin E and NAC (i.e. the placebo of vitamin E as a soft gel capsule and the placebo of NAC as an effervescent tablets along with a glass of water with the same consumption order used in the groups 2 and 3, respectively). Receives: Drug: Placebo oral capsule; Drug: Placebos; Drug: Normal Saline Flush, 0.9% Injectable Solution |
| Vitamin E | Active comparator | Normal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization combined with vitamin E 800 IU orally 2 hours before intervention and 400 IU orally 4 hours after intervention plus the placebo of NAC with a consumption order similar to group 3. Receives: Drug: Vitamin E; Drug: Placebos; Drug: Normal Saline Flush, 0.9% Injectable Solution |
| NAC | Active comparator | Normal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization combined with NAC 1200 mg orally 2 hours before intervention and 1200 mg orally 4 hours after intervention plus the placebo of vitamin E with the consumption order similar to group 2. Receives: Drug: N-acetyl cysteine; Drug: Placebo oral capsule; Drug: Normal Saline Flush, 0.9% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast-induced acute kidney injury
Contrast-induced acute kidney injury defined as an absolute increase ≥0.5 mg/dL or a relative increase ≥25% over baseline serum creatinine concentration within 48-72 hours after administration of contrast media.
Measured: 48 to 72 hours after coronary catheterization
Secondary outcomes (12)
Changes in the levels of serum creatinine
Changes in serum creatinine after coronary artery catheterization
Measured: 48-72 hours post-procedure
eGFR within 48-72 hours after coronary catheterization
Changes in eGFR after coronary artery catheterization
Measured: 48-72 hours post-procedure
Changes in complete blood cell count components from baseline to follow-up
Changes in complete blood cell count components after coronary artery catheterization
Measured: 48-72 hours post-procedure
Length of hospital stay
Length of hospital stay
Measured: 48-72 hours post-procedure
Requirement for renal replacement therapies
Requirement for renal replacement therapies, ie, any kind of dialysis or renal transplantation
Measured: 48-72 hours post-procedure
Post-procedure acute coronary syndrome (ACS) events
Recurrent acute coronary syndrome after coronary artery catheterization
Measured: 48-72 hours post-procedure
Post-procedure cerebrovascular events
Cerebrovascular events after coronary artery catheterization
Measured: 48-72 hours post-procedure
In-hospital mortality
In-hospital mortality after coronary artery catheterization
Measured: 48-72 hours post-procedure
Post-procedure atrial fibrillation
Atrial fibrillation after coronary artery catheterization
Measured: 48-72 hours post-procedure
Post-procedure bleeding
Bleeding events after coronary artery catheterization
Measured: 48-72 hours post-procedure
Pulmonary embolism
Pulmonary embolism after coronary artery catheterization
Measured: 48-72 hours post-procedure
Re-intervention
Repeated coronary artery catheterization
Measured: 48-72 hours post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start1 Nov 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rajaie Cardiovascular Medical and Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755700
- Sponsor's protocol ID
- Intervention-01
- Status last verified
- Nov 2018
- First submitted
- 25 Nov 2018
- Last updated
- 30 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rezaei Y, Khademvatani K, Rahimi B, Khoshfetrat M, Arjmand N, Seyyed-Mohammadzad MH. Short-Term High-Dose Vitamin E to Prevent Contrast Medium-Induced Acute Kidney Injury in Patients With Chronic Kidney Disease Undergoing Elective Coronary Angiography: A Randomized Placebo-Controlled Trial. J Am Heart Assoc. 2016 Mar 15;5(3):e002919. doi: 10.1161/JAHA.115.002919.
PubMed 27068631Rezaei Y, Hemila H. Vitamins E and C May Differ in Their Effect on Contrast-Induced Acute Kidney Injury. Am J Kidney Dis. 2017 May;69(5):708-709. doi: 10.1053/j.ajkd.2016.12.022. Epub 2017 Mar 6. No abstract available.
PubMed 28279510
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antioxidants for Preventing Contrast-Induced Acute Kidney Injury After Coronary Artery Catheterization
- ClinicalTrials.gov ID
- NCT03755700
- Acronym / sponsor ID
- Intervention-01
- Conditions
- Coronary Artery Disease, Coronary Artery Angiography, Coronary Catheterization, Contrast-induced Nephropathy, Stable Angina, Acute Coronary Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Rajaie Cardiovascular Medical and Research CenterUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 28 Nov 2018 (actual)
- 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.
In a double-blinded randomized clinical trial, all patients undergoing coronary artery catheterization who will met our criteria, will be enrolled into three groups to receive either, vitamin e, n-acetylcysteine, or placebo. The aim of study will be to compare the superiority of vitamin e over n-acetylcysteine for the prevention of contrast-induced acute kidney injury (CIAKI).
Detailed description
Patients aged ≥18 years with chronic kidney disease who undergo coronary catheterization will be enrolled into the study if they meet the inclusion criteria. Patients will be randomly assigned into three groups in a 1:1:1 ratio (Computer-generated random number will be used to assign a patient in either group): we will use simple randomization for assigning each patient in a group. The participants, physicians and outcome assessors will be blinded throughout the trial until the opening of the randomization cold.
All patients will be entered into three group and they will be given normal saline 0.9%, vitamin E, NAC, and the placebos of both regimens. The vitamin E will be given as a soft gel capsule and its placebo will have the same shape and taste. The NAC will be given as an effervescent tablet with a glass of water for consumption and its placebo will also have the same shape and taste. These drugs will be given in addition to the routine hydration therapy which will be given to all patients.
Primary outcome will be the development of CIAKI. Secondary outcomes will be the development of major adverse cardiovascular events and any events till evaluating the CIAKI within 48-72 hours after intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo oral capsule, Drug: Placebos, Drug: Normal Saline Flush, 0.9% Injectable SolutionNormal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization combined with the placebos of both vitamin E and NAC (i.e. the placebo of vitamin E as a soft gel capsule and the placebo of NAC as an effervescent tablets along with a glass of water with the same consumption order used in the groups 2 and 3, respectively). |
| Vitamin E | Active comparator | Drug: Vitamin E, Drug: Placebos, Drug: Normal Saline Flush, 0.9% Injectable SolutionNormal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization combined with vitamin E 800 IU orally 2 hours before intervention and 400 IU orally 4 hours after intervention plus the placebo of NAC with a consumption order similar to group 3. |
| NAC | Active comparator | Drug: N-acetyl cysteine, Drug: Placebo oral capsule, Drug: Normal Saline Flush, 0.9% Injectable SolutionNormal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization combined with NAC 1200 mg orally 2 hours before intervention and 1200 mg orally 4 hours after intervention plus the placebo of vitamin E with the consumption order similar to group 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged ≥18 years with baseline estimated glomerular filtration rate (eGFR) <60 mL/min per 1.73 m2 (based on the Modification of Diet in Renal Disease study group formula) who undergo coronary catheterization (i.e. coronary angiography and percutaneous coronary intervention [PCI]) will be invited to the study if they meet the inclusion criteria: stable angina with ischemia and indication for coronary angiography, non-ST-segment elevation (NSTE) acute coronary syndrome (ACS) requiring an early invasive strategy, and patients undergoing elective PCI .
Key exclusion criteria (1 listed)
- acute ST-segment elevation myocardial infarction, high-risk NSTE-ACS warranting emergency coronary angiography (<2 hours), cardiogenic shock, pulmonary edema, overt heart failure and/or ejection fraction <30%, ACS undergoing coronary angiography or angioplasty during the previous 5 days, sensitivity to contrast medium, recent administration of contrast medium for any reason, AKI, history of dialysis, pregnancy, newly prescribed angiotensin converting enzyme inhibitors or angiotensin receptor blockers, bleeding and/or coagulopathy diseases, and consumption of nephrotoxic drugs, vitamin E, vitamin C, or N-acetylcysteine (NAC) at least 48 hours before intervention.
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 |
|---|---|---|
| Vitamin EAs a gel capsule of vitamin E 800 IU orally 2 hours before intervention and 400 IU orally 4 hours after intervention | Drug | Vitamin E |
| N-acetyl cysteineAs an effervescent tablets of NAC 1200 mg orally 2 hours before intervention and 1200 mg orally 4 hours after intervention | Drug | NAC |
| Placebo oral capsuleThe placebo of vitamin E as a soft gel capsule with the consumption order similar to vitamin e group | Drug | NAC, Placebo |
| PlacebosThe placebo of n-acetylcysteine as a tablet with the consumption order similar to n-acetylcysteine group | Drug | Placebo, Vitamin E |
| Normal Saline Flush, 0.9% Injectable SolutionNormal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization | Drug | NAC, Placebo, Vitamin E |
Primary outcome
Contrast-induced acute kidney injury
Time frame: 48 to 72 hours after coronary catheterization
Contrast-induced acute kidney injury defined as an absolute increase ≥0.5 mg/dL or a relative increase ≥25% over baseline serum creatinine concentration within 48-72 hours after administration of contrast media.
12 secondary outcomes
Changes in the levels of serum creatinine
Time frame: 48-72 hours post-procedure
eGFR within 48-72 hours after coronary catheterization
Time frame: 48-72 hours post-procedure
Changes in complete blood cell count components from baseline to follow-up
Time frame: 48-72 hours post-procedure
Length of hospital stay
Time frame: 48-72 hours post-procedure
Requirement for renal replacement therapies
Time frame: 48-72 hours post-procedure
Post-procedure acute coronary syndrome (ACS) events
Time frame: 48-72 hours post-procedure
Post-procedure cerebrovascular events
Time frame: 48-72 hours post-procedure
In-hospital mortality
Time frame: 48-72 hours post-procedure
Post-procedure atrial fibrillation
Time frame: 48-72 hours post-procedure
Post-procedure bleeding
Time frame: 48-72 hours post-procedure
Pulmonary embolism
Time frame: 48-72 hours post-procedure
Re-intervention
Time frame: 48-72 hours post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2018.
- Background: PubMed 27068631Rezaei Y, Khademvatani K, Rahimi B, Khoshfetrat M, Arjmand N, Seyyed-Mohammadzad MH. Short-Term High-Dose Vitamin E to Prevent Contrast Medium-Induced Acute Kidney Injury in Patients With Chronic Kidney Disease Undergoing Elective Coronary Angiography: A Randomized Placebo-Controlled Trial. J Am Heart Assoc. 2016 Mar 15;5(3):e002919. doi: 10.1161/JAHA.115.002919.
- Background: PubMed 28279510Rezaei Y, Hemila H. Vitamins E and C May Differ in Their Effect on Contrast-Induced Acute Kidney Injury. Am J Kidney Dis. 2017 May;69(5):708-709. doi: 10.1053/j.ajkd.2016.12.022. Epub 2017 Mar 6. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin E, N-acetyl cysteine and Normal Saline Flush, 0.9% Injectable Solution in people with Coronary Artery Disease and Coronary Artery Angiography, run by Rajaie Cardiovascular Medical and Research Center at 1 site in Iran.
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 1 inclusion and 1 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 30 Nov 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 Iran. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Yousef Rezaei, MD (+98 91 2623 1864, yousefrezaei1986@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast-induced acute kidney injury (time frame: 48 to 72 hours after coronary catheterization). 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 NCT03755700, which also lists 2 linked publications.
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 Nov 2018.