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

Angina Pectoris Clinical Trial

Official title:

A Real-world Study of Clinical Characteristics, Treatment Patterns and Effectiveness in Chinese Patients With Angina Pectoris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05050773
• Other study ID #: MEDSCI20210407
• Status: Completed
• Start date: September 13, 2021
• Est. completion date: June 10, 2023

Study information

• Verified date: July 2023
• Source: Beijing Anzhen Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1556
• Est. completion date: June 10, 2023
• Est. primary completion date: June 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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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:

1. Imaging examination shows = 50% stenosis and with typical or atypical angina symptoms;

2. 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;

3. 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.

Related Conditions & MeSH terms

• Angina Pectoris

Locations

Country	Name	City	State
China	Anzhen Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Changping District Hospital	Beijing	Beijing
China	Beijing Daxing District People's Hospital	Beijing	Beijing
China	Beijing Huaxin Hospital	Beijing	Beijing
China	Beijing Jishuitan Hospital	Beijing	Beijing
China	Beijing Miyun District Hospital	Beijing	Beijing
China	Beijing Shijitan Hospital	Beijing	Beijing
China	Dezhou People's Hospital	Dezhou	Shandong
China	Huai'an Hospital of Traditional Chinese Medicine	Huai'an	Jiangsu
China	Ruyang People's Hospital	Luoyang	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital	Beijing Life oasis public service center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SAQ-SS change at Month 12	Change in Seattle Angina Questionnaire (SAQ) summary score at Month 12 from baseline	at Month 12
Secondary	SAQ-SS change at Month 3, 6 and 9	Changes in Seattle Angina Questionnaire (SAQ) summary score at Months 3, 6, and 9 from baseline	at Month 3, 6 and 9
Secondary	Vascular stenosis degree change at Month 12	Changes in retest results of vascular stenosis imaging at Month 12 from baseline	at Month 12
Secondary	Medication compliance	Medication compliance evaluated by proportion of days covered (PDC)	12 Month