Angina PectorisNCT05050773
Registry Study of Medical Therapy in Patients With Angina Pectoris(GREAT)
An observational study of Angina Pectoris and Real World Study, run by Beijing Anzhen Hospital at 10 sites in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Angina Pectoris, Real World Study
- How many people
- 1,556 participants
- Where
- 10 sitesChina
- Study dates
- 13 Sep 2021to 10 Jun 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: angina pectoris patients
Who may be able to join
- -
- 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:
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
Beijing Changping District Hospital
Beijing, Beijing Municipality
Beijing Daxing District People's Hospital
Beijing, Beijing Municipality
Beijing Huaxin Hospital
Beijing, Beijing Municipality
Beijing Jishuitan Hospital
Beijing, Beijing Municipality
Beijing Miyun District Hospital
Beijing, Beijing Municipality
Beijing Shijitan Hospital
Beijing, Beijing Municipality
Dezhou People's Hospital
Dezhou, Shandong
Huai'an Hospital of Traditional Chinese Medicine
Huai'an, Jiangsu
Ruyang People's Hospital
Luoyang, Henan
About this study
Official title: 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.
Read the 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.
- Conditions
- Angina Pectoris, Real World Study
- Keywords
- Angina Pectoris, Real World Study, Nicorandil
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
SAQ-SS change at Month 12
Change in Seattle Angina Questionnaire (SAQ) summary score at Month 12 from baseline
Measured: at Month 12
Secondary outcomes (3)
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
Measured: 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
Measured: at Month 12
Medication compliance
Medication compliance evaluated by proportion of days covered (PDC)
Measured: 12 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start13 Sep 2021
- Primary completion10 Jun 2023
- Study completion10 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,556 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Life oasis public service center
- Responsible party
- Principal investigator, Yong Zeng, Beijing Anzhen Hospital
- Investigators
- Yong Zeng, MD, Principal investigator, Anzhen hospital, Capital medical universityXiliang Zhao, MD, Study director, Anzhen hospital, Capital medical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050773
- Sponsor's protocol ID
- MEDSCI20210407
- Status last verified
- Jul 2023
- First submitted
- 10 Sep 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhao X, Cheng G, Sun L, Liu Y, Du X, Xu S, Wu L, Wei Y, Liu W, Miao L, Zhang Q, Ma C, Zeng Y. Nicorandil Use and Health Status Outcomes in Patients with Angina Pectoris: A Prospective, Multicenter, Cohort Study (GREAT). Drug Des Devel Ther. 2025 Sep 15;19:8295-8308. doi: 10.2147/DDDT.S506108. eCollection 2025.
PubMed 40980423Wu Y, Zhao X, Cheng G, Sun L, Liu Y, Xu S, Wu L, Wei Y, Liu W, Miao L, Zhang Q, Ma C, Zeng Y, Du X. Sex differences in health status trajectories among Chinese angina patients: a post-hoc analysis of the GREAT multicenter prospective cohort. BMC Cardiovasc Disord. 2025 Jul 28;25(1):546. doi: 10.1186/s12872-025-04991-3.
PubMed 40717100Zhao X, Tong Z, Sun L, Zhang Q, Du X, Xu S, Shen C, Wei Y, Liu W, Miao L, Zeng Y. Clinical Characteristics, Treatment Patterns, and Effectiveness in Chinese Patients with Angina Pectoris Using Electronic Patient-Reported Outcomes: Protocol for a Multicenter, Prospective, Cohort Study (GREAT). Adv Ther. 2023 Apr;40(4):1899-1912. doi: 10.1007/s12325-023-02425-0. Epub 2023 Feb 4.
PubMed 36737594
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study of Clinical Characteristics, Treatment Patterns and Effectiveness in Chinese Patients With Angina Pectoris
- ClinicalTrials.gov ID
- NCT05050773
- Acronym / sponsor ID
- MEDSCI20210407
- Conditions
- Angina Pectoris, Real World Study
- Keywords
- Angina Pectoris, Real World Study, Nicorandil
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,556 participants (actual)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Collaborators
- Beijing Life oasis public service center
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 10 Jun 2023 (actual)
- Study completion
- 10 Jun 2023 (actual)
- First posted
- 21 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- angina pectoris patients
Key inclusion criteria (5 listed)
- -
- 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:
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SAQ-SS change at Month 12
Time frame: at Month 12
Change in Seattle Angina Questionnaire (SAQ) summary score at Month 12 from baseline
3 secondary outcomes
SAQ-SS change at Month 3, 6 and 9
Time frame: at Month 3, 6 and 9
Vascular stenosis degree change at Month 12
Time frame: at Month 12
Medication compliance
Time frame: 12 Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Derived from this study: PubMed 40980423Zhao X, Cheng G, Sun L, Liu Y, Du X, Xu S, Wu L, Wei Y, Liu W, Miao L, Zhang Q, Ma C, Zeng Y. Nicorandil Use and Health Status Outcomes in Patients with Angina Pectoris: A Prospective, Multicenter, Cohort Study (GREAT). Drug Des Devel Ther. 2025 Sep 15;19:8295-8308. doi: 10.2147/DDDT.S506108. eCollection 2025.
- Derived from this study: PubMed 40717100Wu Y, Zhao X, Cheng G, Sun L, Liu Y, Xu S, Wu L, Wei Y, Liu W, Miao L, Zhang Q, Ma C, Zeng Y, Du X. Sex differences in health status trajectories among Chinese angina patients: a post-hoc analysis of the GREAT multicenter prospective cohort. BMC Cardiovasc Disord. 2025 Jul 28;25(1):546. doi: 10.1186/s12872-025-04991-3.
- Derived from this study: PubMed 36737594Zhao X, Tong Z, Sun L, Zhang Q, Du X, Xu S, Shen C, Wei Y, Liu W, Miao L, Zeng Y. Clinical Characteristics, Treatment Patterns, and Effectiveness in Chinese Patients with Angina Pectoris Using Electronic Patient-Reported Outcomes: Protocol for a Multicenter, Prospective, Cohort Study (GREAT). Adv Ther. 2023 Apr;40(4):1899-1912. doi: 10.1007/s12325-023-02425-0. Epub 2023 Feb 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Zeng, MD principal investigator
Anzhen hospital, Capital medical university
Xiliang Zhao, MD study director
Anzhen hospital, Capital medical university
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angina Pectoris and Real World Study, run by Beijing Anzhen Hospital at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAQ-SS change at Month 12 (time frame: at Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05050773, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.