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Efficacy Study of Oral Nicorandil on Improving Microvascular Function in Female Non-obstructive Coronary Artery Disease (CAD) Participants | Clinical Trials | Clareo Health

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Efficacy Study of Oral Nicorandil on Improving Microvascular Function in Female Non-obstructive Coronary Artery Disease (CAD) Participants

An Interventional, Pilot Study to Evaluate the Efficacy of Oral Nicorandil on Improving Microvascular Function in Female Non-obstructive CAD Patients (SPET Study)

NCT03010423•Merck KGaA, Darmstadt, Germany

View on ClinicalTrials.gov

Summary

The study is a single-center, interventional, pilot study to evaluate the improvement of microvascular function by positron emission tomography (PET) after twelve-week treatment of oral nicorandil in female non-obstructive CAD Participants.

Eligibility

Age

18 - 70 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Female
•Participants aged 18-70 years
•Participants with typical stable angina but without coronary obstruction (defined as coronary occlusion less than (\<) 50%) by invasive coronary angiography or coronary computed tomography angiography (CTA) in recent three months
•All other long acting cardiovascular disease medicines, including but not limited to aspirin/clopidogrel, calcium channel blockers (CCB), Angiotensin-converting enzyme inhibitors (ACEI)/Angiotensin II Receptor Blockers (ARB), beta-blockers, statins, ivabradine, trimetazidine, et al, should be stable taken for at least two weeks before screening period
•For participants who met these four criteria above, MFR will be tested by stress PET. Participants whose MFR \<3.0 could be included in the study

Exclusion Criteria

•Severe or uncontrolled hypertension (resting Systolic blood pressure \[SBP\] \>=160 millimeter of mercury (mmHg), or resting Diastolic blood pressure \[DBP\] \>=100mmHg at screening period)
•Participants with shock (including cardiogenic shock), or hypovolemia
•Severe hypotension (resting SBP\<90mmHg，or resting DBP\<60mmHg)
•Significant valvular heart disease, congenital heart disease or cardiomyopathy
•Congestive heart failure(New York Heart Association \[NYHA\] III-IV), echocardiographic ejection fraction\<45%
•Acute pulmonary edema;
•Hepatic or renal dysfunction, defined as:
•* Serum Alanine Aminotransferase (ALT) \> triple of the normal value upper limit;
•* Serum Aspartate Aminotransferase (AST) \> triple of the normal value upper limit
•* Serum creatinine \> twice of the normal value upper limit
+10 more criteria

Locations (1)

Peking union medical college hospital

Beijing, China

Key Dates

Start Date

November 30, 2016

Primary Completion Date

July 9, 2019

Completion Date

July 9, 2019

Last Updated

July 7, 2020

Enrollment

ACTUAL participants

Conditions

Non-obstructive Coronary Artery Disease

Interventions

Nicorandil

DRUG

Coronary Microvascular Dysfunction in Angina Patients With Non-obstructive Coronary Artery Disease (ANOCA-CMD)

NCT06503640

Angina Patients With Non-obstructive Coronary Artery DiseaseCoronary Microvascular Dysfunction+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 7, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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