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ComparIson of protective effect on coroNary Microcirculation of Single dose of oral nicorandil and intravenous nicorandil in Patients undergoIng selective peRcutaneous coronary intervEntion

ComparIson of protective effect on coroNary Microcirculation of Single dose of oral nicorandil and intravenous nicorandil in Patients undergoIng selective peRcutaneous coronary intervEntion

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800020073
Enrollment
Unknown
Registered
2018-12-13
Start date
2016-11-22
Completion date
Unknown
Last updated
2018-12-18

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

Conditions

coronary heart disease

Interventions

control group:According to the routine PCI process, no research drugs were used before operation.
Oral group:0.5 to 1 hours before PCI, nicorandil 20mg was taken.
Venous group:Intravenous injection of nicorandil injection 6mg immediately after PCI

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18~80 years old male and female; 2) patients who were diagnosed with coronary heart disease with PCI operation; 3) he or his legal representative agrees to sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) coronary angiography is not suitable for PCI; 2) CABG surgery had been performed in the past; 3) acute ST segment elevation myocardial infarction over the past 7 days; 4) patients with non ST segment elevation acute coronary syndrome receiving emergency PCI treatment; 5) the target vessels were chronic complete occlusion; 6) left or right coronary opening lesions; 7) target vessel is infarct related artery, whether it is old myocardial infarction or acute myocardial infarction convalescence; 8) the immediate effect of PCI on the target vessel was not satisfactory (such as the final TIMI blood flow 1.5mm, the distal embolism or the thrombus showing the presence of contrast); 9) anaphylaxis to nicorandil, nicotinic acid or contrast agent; 10) glaucoma; 11) an erectile dysfunction therapy agent (sildenafil citrate, nicotinic acid, and TEDA) is being taken with the 5 blockage of phosphodiesterase; 12) the use of nicorandil in the past 7 days; 13) severe heart failure, cardiac function grade III or above (angina pectoris patients using NYHA classification, acute myocardial infarction patients using Killip's classification); 14) the systolic pressure was less than 90 mmHg; 15) severe bradycardia (HR < 50 / min) or II~III degree atrioventricular block; 16) atrial fibrillation or atrial flutter; 17) the history of asthma or the history of severe COPD; 18) eGFR < 30 ml/min; 19) abnormal platelet count or coagulation dysfunction; 20) the history of malignant tumor or autoimmune disease; 21) severe infection; 22) women in pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
Microcirculation resistance index;

Secondary

MeasureTime frame
CKMB;hs-TnT or cTnI;

Countries

China

Contacts

Public ContactLijun Guo

Peking University Third Hospital

guo_li_jun@126.com+86 13601234630

Outcome results

None listed

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