Brief Summary

The study will be a multi-center, prospective, cohort study based on registration of Chinese angina pectoris patients. After signing the informed consent, all patients will be screened as per the inclusion and exclusion criteria. Estimated 1500 eligible patients will be enrolled. Two natural cohort will be formed according to whether Nicorandil will be prescribed to patients or not. The baseline information of patients will be recorded and patients will be followed up to observe the effectiveness of different anti-angina regimens. Follow-up visits will be conducted at Month 3, 6, 9, 12 after enrollment. The visits at Months 3, 6 and 9 will be conducted in the form of electronic patient reported outcomes (ePRO) + telephone follow-up, and the visit at Month 12 will be conducted on site. Patients are required to fill in the patient diary records (weekly) during the course of the study. This study is designed to establish a cohort of Chinese angina pectoris patients and compare the effectiveness of different anti-angina regimens in patients with angina pectoris.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,556

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Sep 2021

Geographic Reach

1 country

10 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.7 years study duration

First Submitted

Initial submission to the registry

September 10, 2021

Completed

3 days until next milestone

Study Start

First participant enrolled

September 13, 2021

Completed

8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2021

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2023

Completed

Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

1.7 years

First QC Date

September 10, 2021

Last Update Submit

July 31, 2023

Conditions

Angina Pectoris Real World Study

Keywords

Angina PectorisReal World StudyNicorandil

Outcome Measures

Primary Outcomes (1)

SAQ-SS change at Month 12
Change in Seattle Angina Questionnaire (SAQ) summary score at Month 12 from baseline
at Month 12

Secondary Outcomes (3)

SAQ-SS change at Month 3, 6 and 9
at Month 3, 6 and 9
Vascular stenosis degree change at Month 12
at Month 12
Medication compliance
12 Month

Study Arms (2)

Nicorandil group

Patients who are prescribed with Nicorandil with or without other concomitant medication

Non-Nicorandil group

Patients who are prescribed with antianginal drugs except Nicorandil

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

angina pectoris patients

You may qualify if:

\. Patients with angina pectoris who have evidence of coronary angiography or coronary computed tomography angiography (CTA) performed within 1 year and meet any of the following requirements:
Imaging examination shows ≥ 50% stenosis and with typical or atypical angina symptoms;
Imaging examination shows \< 50% stenosis; with typical or similar angina symptoms, and the treadmill exercise test or stress echocardiography or radionuclide stress test results are positive;
Post-PCI stenosis of left vessels is ≥ 50%; 2. Currently taking or judged by the physicians as suitable to taking at least one oral antianginal drug (e.g., beta-blockers, nitrates, calcium antagonists and potassium channel openers); 3. Have basic reading and writing abilities, and can correctly fill in the Seattle Angina Questionnaire(SAQ) after being trained by the investigator; 4. Able to use smart phones; 5. Voluntarily participate in the study and sign the informed consent form.

You may not qualify if:

Have been diagnosed with malignant tumors that seriously threaten survival and have expected survival time of less than 1 year;
Have participated in other clinical studies within the past 1 month;
With poor compliance or with other conditions unsuitable for this study as assessed by physicians.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Beijing Anzhen Hospitallead
Beijing Life oasis public service centercollaborator

Study Sites (10)

Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

Beijing Changping District Hospital