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A prospective, randomized, double-blind, controlled study for ATP-sensitive potassium channel openers in the treatment of primary coronary microvascular disease.

A prospective, randomized, double-blind, controlled study for ATP-sensitive potassium channel openers in the treatment of primary coronary microvascular disease.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022978
Enrollment
Unknown
Registered
2019-05-06
Start date
2019-06-01
Completion date
Unknown
Last updated
2019-05-13

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

Conditions

Coronary Microvascular Disease

Interventions

Control group:Placebo
Experiment group:Nicorandil

Sponsors

Beijing Hospital, National Center of Gerontology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18 to 75 years old; (2) The subjects were patients with typical exertional angina pectoris; (3) The subject (or legal guardian) understands the research requirements and treatment procedures and can provide written informed consent before conducting a specific examination or procedure; (4) The participants were willing to follow up the clinical and follow-up evaluation required by the research program, including consent and tolerance to stress myocardial SPECT (exercise or ATP stress), coronary angiography, coronary flow reserve or acetylcholine provocation test.

Exclusion criteria

Exclusion criteria: 1. The subjects were suspected of unstable angina pectoris or acute myocardial infarction; 2. The subjects have received or are waiting for organ transplantation; 3. Within 30 days before and after the operation, the subjects were receiving or planning to receive chemotherapy; 4. The subjects were allergic to iodine contrast agent, adenosine, acetylcholine or nicorandil; 5. The subjects were known to have the following information (based on the evaluation at the time of screening): (1) Life expectancy may be reduced to other serious diseases (such as cancer, congestive heart failure) less than 24 months; (2) Current problems of drug abuse (e.g. alcohol, cocaine, heroin, etc.); (3) Planned acceptance may lead to non-compliance or confusion in data understanding; 6. The subjects were receiving long-term (> 72 hours) anticoagulation therapy (such as heparin and warfarin) for diseases other than acute coronary syndrome (ACS); 7. The whole blood cell count (CBC) of the subjects is beyond the scope, and it is of clinical significance confirmed by doctors; 8. The subjects had definite or suspected liver diseases, including laboratory evidence of hepatitis; 9. The subjects were undergoing dialysis or baseline serum creatinine levels > 2.0 mg/dL (177 mol/L); 10. The subjects tended to bleed or had a history of coagulation disease or refused blood transfusion; 11. The subjects had active gastric ulcer or active gastrointestinal bleeding; 12. The subjects are participating in clinical studies of other research drugs or devices, and have not reached their primary endpoint; 13. The subjects were pregnant or lactating women (women of childbearing age had to undergo pregnancy tests within 7 days before entering the procedure).

Design outcomes

Primary

MeasureTime frame
Scope of myocardial perfusion defect;

Countries

China

Contacts

Public ContactHuiping Zhang

Beijing Hospital, National Center of Gerontology, No 1 DaHua Road, Dong Dan, Beijing 100730, China

huipingzhang73@163.com+86 13911879076

Outcome results

None listed

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