The Effect of Spironolactone on Acute Kidney Injury in Patients Undergoing Coronary Angiography

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

490 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-09-04

Brief Summary

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an interventional study to measure the possible effects of spironolactone ( an aldosterone antagonist) on the incidence of acute kidney injury after coronary angiography

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Detailed Description

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Conditions

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Acute Kidney Injury IHD Contrast-induced Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Each patient will receive a placebo tablet as per his/her angiography premedications

Spironolactone

Group Type ACTIVE_COMPARATOR

Spironolactone

Intervention Type DRUG

each patient will receive 200 mg of spironolactone as per his/her angiography premedications

Interventions

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Spironolactone

each patient will receive 200 mg of spironolactone as per his/her angiography premedications

Intervention Type DRUG

Placebo Oral Tablet

Each patient will receive a placebo tablet as per his/her angiography premedications

Intervention Type DRUG

Other Intervention Names

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Active group Control group

Eligibility Criteria

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Inclusion Criteria

* patients admitted to angiography unit
* over 18
* informed consent

Exclusion Criteria

* acute renal failure before 7 days
* spironolactone contraindications
* hyperkalemia (S.K. \>5.5 mEq/L)
* documented tumor
* actively taking NSAIDs, Ciclosporin, Cisplatin,

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Alhasan Mujtaba Abdul-Wahid

Clinical pharmacy specialist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Alhasan Mujtaba, BCPS

Role: PRINCIPAL_INVESTIGATOR

Baghdad University/College of Pharmacy/Department of Clinical Pharmacy

Mohammed A Taher, Ph.D.

Role: STUDY_CHAIR

Baghdad University/College of Pharmacy/Department of Biochemistry