Vitamin E and N-acetylcysteine for Preventing Contrast-Induced Acute Kidney Injury After Coronary Artery Catheterization

Rajaie Cardiovascular Medical and Research Center

Status and phase: Unknown; Phase 3

Conditions: Coronary Artery Disease; Acute Coronary Syndrome; Stable Angina; Coronary Catheterization; Coronary Artery Angiography; Contrast-induced Nephropathy

Treatments: Drug: Normal Saline Flush, 0.9% Injectable Solution; Drug: N-acetyl cysteine; Drug: Vitamin E; Drug: Placebos; Drug: Placebo oral capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT03755700

Intervention-01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,000 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Drug: Placebo oral capsule

Drug: Normal Saline Flush, 0.9% Injectable Solution

Drug: Placebos

Vitamin E

Active Comparator group

Description:

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.

Treatment:

Drug: Normal Saline Flush, 0.9% Injectable Solution

Drug: Vitamin E

Drug: Placebos

NAC

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo oral capsule

Drug: N-acetyl cysteine

Drug: Normal Saline Flush, 0.9% Injectable Solution