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Clinical trial

Possible Role of Coenzyme Q10 in Prevention of Contrast Induced Nephropathy in Patients With Acute Coronary Syndrome Undergoing Coronary Angiography With or Without Intervention.

ID
Name
MS70/2024
Description
In this study the investigators aim to study the effect of supplementation of CoQ10 in decreasing the incidence of contrast induced acute kidney injury in patients with acute coronary syndrome undergoing coronary angiography.
Trial arms
Trial start
2024-06-01
Estimated PCD
2024-10-01
Trial end
2024-11-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Coenzyme Q10 100 Milligrams Oral Capsule
Patients will be randomly divided into two groups using a computer generated random number chart Coenzyme Q10 group will receive 400 milligrams coenzyme Q10 preoperative and 400 milligrams coenzyme Q10 for 3 days post operative in addition to the standard preventive measures.
Arms:
Coenzyme Q10 100 Milligrams Oral Capsule
Other names:
Coenzyme Q10
Placebo
placebo group will receive only the standard preventive measures (as proper hydration pre and post operative)without the coenzyme Q10.
Arms:
Placebo group
Size
250
Primary endpoint
Percentage of the Creatinine rise in 1st 48-72 hours in ccu
48-72 hours
Eligibility criteria
Inclusion Criteria: * Patients who are 18 years or older. * ST-elevation myocardial infarction (STEMI). * Non ST-elevation myocardial infarction( NSTEMI). * Unstable Angina (UA) Exclusion Criteria: * Renal transplant patients. * Preoperative bleeding . * Intraoperative bleeding or hypotension. * Patients taking any nephrotoxic medications
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 250, 'type': 'ESTIMATED'}}
Updated at
2024-06-04

1 organization

1 product

1 drug

1 indication

Organization
Ain Shams University
Product
Coenzyme Q10
Indication
Contrast-induced Nephropathy
Drug
Varlilumab