Preventive Effect of the PRetreatment With Intravenous Nicorandil on Contrast-Induced Nephropathy in Patients With RenaL Dysfunction UndEergoing Coronary Angiography (PRINCIPLE Study)

Browse trials for

• Renal Insufficiency 1,995
• Kidney Failure, Chronic 2,086

Keywords

• Patients with chronic renal failure undergoing coronary angiography

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 172 are open to participants now.

This study's enrollment of 173 is above the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 231 are open to participants now.

Study arms

• Experimental
  Nicorandil in saline

  Drug: pretreatment with intravenous nicorandil vs. placebo before coronary angiography

• Placebo comparator
  saline

  Drug: pretreatment with intravenous nicorandil vs. placebo before coronary angiography

Interventions

• Drugpretreatment with intravenous nicorandil vs. placebo before coronary angiography

  * Nicorandil group: Pretreatment with intravenous Nicorandil (Sigmart for injection, Choongwae Pharma, Seoul) 12 mg in 0.9% saline 100 ml over 2 hours starting from 1 hour prior to coronary angiography * Control group: Pretreatment with intravenous 0.9% saline 100 ml over 2 hours starting from 1 hour prior to coronary angiography

  Also known as: Nicorandil group versus Control group

Primary outcomes

1. Incidence of contrast-induced nephropathy defined as an increase in serum creatinine ≥25% or ≥0.5 mg/dl

   Time frame: at 24 hours