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

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

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.

Study Overview

• Status: Completed
• Conditions: Angina Pectoris; Real World Study

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 Type: Observational
• Enrollment (Actual): 1556

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Beijing Shijitan Hospital
    • Beijing, Beijing, China
      • Beijing Jishuitan Hospital
    • Beijing, Beijing, China, 100029
      • 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 Miyun District Hospital
  • Henan
    • Luoyang, Henan, China
      • Ruyang People's Hospital
  • Jiangsu
    • Huai'an, Jiangsu, China
      • Huai'an Hospital of Traditional Chinese Medicine
  • Shandong
    • Dezhou, Shandong, China
      • Dezhou People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

angina pectoris patients

Description

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:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SAQ-SS change at Month 12	Change in Seattle Angina Questionnaire (SAQ) summary score at Month 12 from baseline	at Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Vascular stenosis degree change at Month 12	Changes in retest results of vascular stenosis imaging at Month 12 from baseline	at Month 12
Medication compliance	Medication compliance evaluated by proportion of days covered (PDC)	12 Month

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Collaborators: Beijing Life oasis public service center
• Investigators: Principal Investigator: Yong Zeng, MD, Anzhen Hospital, Capital Medical University; Study Director: Xiliang Zhao, MD, Anzhen Hospital, Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2021
• Primary Completion (Actual): June 10, 2023
• Study Completion (Actual): June 10, 2023

Study Registration Dates

• First Submitted: September 10, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 21, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Nicorandil; Angina Pectoris; Real World Study
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris
• Other Study ID Numbers: MEDSCI20210407

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No