Antioxidants for Preventing Contrast-Induced Acute Kidney Injury After Coronary Artery Catheterization
| Registry | NCT03755700 |
|---|---|
| Status | Unknown |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: double, prevention |
| Enrollment | 1000 (Estimated) |
| Sponsor | Rajaie Cardiovascular Medical and Research Center (Other) |
| Conditions | Coronary Artery Disease, Coronary Artery Angiography, Coronary Catheterization, Contrast-induced Nephropathy, Stable Angina, Acute Coronary Syndrome |
| Interventions | Vitamin E, N-acetyl cysteine, Placebo oral capsule, Placebos, Normal Saline Flush, 0.9% Injectable Solution (Drug) |
| Dates | start 2018-11-01, primary completion 2019-12-31 (estimated), completion 2019-12-31 (estimated), first posted 2018-11-28, last updated 2018-11-30 |
| Locations | 1 site in Iran |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Coronary Artery Disease All trials for Coronary Artery Angiography All trials of Vitamin E All trials of N-acetyl cysteine
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).
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo oral capsule; Drug: Placebos; Drug: Normal Saline Flush, 0.9% Injectable Solution | 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). |
| Vitamin E | Active comparator | Drug: Vitamin E; Drug: Placebos; Drug: Normal Saline Flush, 0.9% Injectable Solution | 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. |
| NAC | Active comparator | Drug: N-acetyl cysteine; Drug: Placebo oral capsule; Drug: Normal Saline Flush, 0.9% Injectable Solution | 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. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: 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 . Exclusion Criteria: 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.
| Facility | City | Country | Status |
|---|---|---|---|
| Rajaie cardiovascular medical and research center | Tehran | Iran | Recruiting |