Registry Study of Medical Therapy in Patients With Angina Pectoris(GREAT)

Completed

• Conditions: Angina Pectoris; Real World Study

• Registration Number: NCT05050773
• Lead Sponsor: Beijing Anzhen Hospital

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.

Detailed Description

After having signed informed consent (Day 0), the patients will be screened for enrollment. About 1500 eligible patients will be enrolled in this study. The basic information of eligible patients including demographic characteristics, history of present illness, past history, Rose questionnaire, vital sign, medication information, SAQ and other optional examination data will be collected at Day 0. At Day 0, the patients will join the study Wechat Mini Program developed for online follow up and patient education by scan the QR code provided by investigators. After enrollment, the following information will be collected by ePRO with WeChat Mini Program or telephone follow up of month 3, 6 and 9: vital sign, medication information, SAQ, AE. The follow up of month 12 will be conducted on site which will collect SAQ, AE and other optional examination data.

Study Timeline

• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-09-10
• Study Start: 2021-09-13
• Study First Posted: 2021-09-21
• Primary Completion: 2023-06-10
• Study Completion: 2023-06-10
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-31
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1556

Inclusion Criteria

1. 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:

2. Imaging examination shows ≥ 50% stenosis and with typical or atypical angina symptoms;

3. 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;

4. 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.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
SAQ-SS change at Month 3, 6 and 9	at Month 3, 6 and 9	Changes in Seattle Angina Questionnaire (SAQ) summary score at Months 3, 6, and 9 from baseline
Vascular stenosis degree change at Month 12	at Month 12	Changes in retest results of vascular stenosis imaging at Month 12 from baseline
Medication compliance	12 Month	Medication compliance evaluated by proportion of days covered (PDC)

Trial Locations

Locations (10)

Beijing Changping District Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Miyun District Hospital; 🇨🇳 Beijing, Beijing, China

Dezhou People's Hospital; 🇨🇳 Dezhou, Shandong, China

Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Huaxin Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Daxing District People's Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Shijitan Hospital; 🇨🇳 Beijing, Beijing, China

Ruyang People's Hospital; 🇨🇳 Luoyang, Henan, China

Huai'an Hospital of Traditional Chinese Medicine; 🇨🇳 Huai'an, Jiangsu, China

Beijing Jishuitan Hospital; 🇨🇳 Beijing, Beijing, China