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Effects of oral nicorandil on contrast-induced nephropathy in coronary artery disease with renal insufficiency after percutaneous coronary intervention

Effects of oral nicorandil on contrast-induced nephropathy in coronary artery disease with renal insufficiency after percutaneous coronary intervention

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17012805
Enrollment
Unknown
Registered
2017-09-26
Start date
2017-11-01
Completion date
Unknown
Last updated
2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

contrast induced nephropathy

Interventions

nicorandil group:oral treatment with nicorandil (sigmart, Nipro Pharma Corporation Kagamiishi Plant), 5mg 3 times/day, from 2 days before and to 3 days after contrast medium administration
control group:the control group did not receive any nicorandil

Sponsors

Department of Cardiology, Zhongda Hospital of Southeast University Medical School
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) volunteered to participate in this trial and signed informed consent; (2) Aged 18 to 80 Years; (3) Planned percutaneous coronary intervention(PCI); (4) CKD stages 2,3, eGFR 30 to 89ml/min per 1.73m2; (5) coronary artery disease.

Exclusion criteria

Exclusion criteria: (1) received any nicorandil at least 14 days before randomization; (2) Hypersensitivity to iodine-containing compounds; (3) eGFR=90ml/min per 1.73m2 or eGFR<30ml/min per 1.73m2); (4) acute ST-segment elevation myocardial infarction (STEMI); (5) NYHA class IV or hemodynamic instability;; (6) Take CT, MRI and other examinations with contrast agents during the two weeks before study; take radiographic examination of other contrast agents during the study period; (7) blood pressure <120/80mmHg; (8) Hepatic dysfunction (ALT 3 times greater than upper normal limit); (9) Thyreoid insufficiency; (10) Malignant tumors, inflammatory diseases, autoimmune diseases.

Design outcomes

Primary

MeasureTime frame
Primary Outcome Measures:The incedence of CIN;

Secondary

MeasureTime frame
Secondary Outcome Measures: The composite of hospitalization for aggravated renal function, acute renal failure, dialysis or hemofiltration, aggravated at least 1 class of heart function, acute left ventricular failure or death from all causes occurring within 30 days after contrast.;

Countries

China

Contacts

Public ContactChengchun Tang

Department of Cardiology, Zhongda Hospital of Southeast University Medical School

tangchengchun@medmail.com.cn+86 13914705570

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026