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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-07-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-obstructive Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nicorandil

Group Type EXPERIMENTAL

Nicorandil

Intervention Type DRUG

Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.

Interventions

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Nicorandil

Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.

Intervention Type DRUG

Eligibility Criteria

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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
* Glaucoma
* Active peptic ulcer or active skin ulcer
* Taking glyburide, phosphodiesterase type 5 (PDE-5) inhibitor, soluble guanylate cyclase stimulator(s)
* Known to be hypersensitivity to nicorandil, nitrates, niacin, or any of the excipient
* With contraindication to complete stress PET test
* No legal ability and legal ability is limited
* Participants unlikely to cooperate in the study or with inability or unwillingness to give informed consent
* Child-bearing period women without effective contraceptive measures, pregnancy and lactation
* Participation in another clinical trial within the past 30 days
* Other significant disease that in the Investigator's opinion would exclude the participant from the trial

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No