An interventional study of COM-B and HAPA-based Self-management Support Program and Routine Health Education in Acute Coronary Syndrome (ACS), sponsored by Nanfang Hospital, Southern Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Nanfang Hospital, Southern Medical University · Not applicable, Interventional, and Supportive care
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Among 185 studies in Acute Coronary Syndrome with a site in China — 56 open to participants now, 63 under way, 3 of them phase 3. Acute Coronary Syndrome · China.
Among the 185 studies in Acute Coronary Syndrome with a site in China, this one is the 99th largest by planned enrollment of the 115 interventional ones that give a count, is one of 10 that started in 2026, is one of 47 with no phase, reaches primary completion later than 48 of the 62 other live ones, and was the 182nd registered.
1,490 studies on the registry are indexed under Acute Coronary Syndrome; 272 are open to participants now.
Browse Acute Coronary Syndrome studies →56 of the 185 studies in Acute Coronary Syndrome with a site in China are open now. Recruiting first, the newest first:
Shenyang Northern Hospital · Sites in China
Ages 18+
Xiling Qi · Sites in China
Ages up to 85
Jilin University · Sites in China
Ages 18–85
Jing Han · Sites in China
Ages 18+
China National Center for Cardiovascular Diseases · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 196 Acute Coronary Syndrome studies recruiting now, 145 (74%) set no upper age limit and 19 (10%) stop at 75 or younger; 15 take children under 18; 15 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
185 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 2 · Phase 3 14 · Phase 4 47
First in 2005; this study’s year is marked. 10 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 80 is below the median of 200 across 867 interventional studies indexed under Acute Coronary Syndrome.
Median enrollment 499 across the 115 interventional studies, 1,312 across the 70 observational. Of the 67 that completed or were terminated, 12 (18%) have results posted.
This tab as a report to print or save as PDF → With an account.
27 of 185 have an industry lead sponsor. The 10 most frequent:
Nanfang Hospital, Southern Medical University is the lead sponsor of 490 studies on the registry; 214 are open to participants now.
Nanfang Hospital, Southern Medical University has 1 study filed under Acute Coronary Syndrome — fewer than ten, so there is no comparison to draw.
18 of the studies in Acute Coronary Syndrome with a site in China that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06577519Phase 3Jiangsu vcare pharmaceutical technology co., LTDEfficacy and Safety Study of Vicagrel in Patients With Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI) | 2026-12-30 |
| NCT07102628Phase 3Novartis PharmaceuticalsEvaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes | 2027-02-11 |
| NCT05325034Stephen NichollsGuideline Oriented Approach To Lipid Lowering In Asia-Pacific | 2026-12 |
| NCT05638867China National Center for Cardiovascular DiseasesNOAC Therapy Guided by PARIS Risk Score and D-dimer in Patients With ACS After PCI | 2026-12 |
| NCT05457582Nanjing First Hospital, Nanjing Medical UniversityPCSK 9 Inhibitor Added to High-Intensity Statin Therapy to Prevent Cardiovascular Events in Patients With ACS After PCI | 2026-12-30 |
Add all 18 to your calendar (.ics) → With an account.
Among the 185 studies in Acute Coronary Syndrome with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This randomized controlled trial evaluates a "Hospital-to-Home" self-management support model for Acute Coronary Syndrome (ACS) patients, which is based on the integrated COM-B and HAPA theories. Participants are randomly assigned to either an intervention group receiving a structured self-management program or a control group receiving standard education. The study compares self-management behaviors and health outcomes between the two groups to assess the model's effectiveness.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive the structured self-management support program based on the integrated COM-B and HAPA models, including enhanced education and follow-up support.
Behavioral: COM-B and HAPA-based Self-management Support Program
Participants receive standard care and routine health education.
Behavioral: Routine Health Education
This intervention is based on the integrated HAPA and COM-B models. Using HAPA, patients are categorized into three phases: pre-action (contemplation), action initiation (early post-discharge), and behavior maintenance (≥1 month post-discharge). Prior to discharge, a COM-B assessment identifies individual barriers and facilitators across capability, opportunity, and motivation. Tailored self-management support is then delivered according to the patient's phase and COM-B profile. The core intervention consists of one in-depth inpatient interview and three outpatient sessions for self-management planning, execution, and confirmation.
Participants receive routine health education and standard care according to the hospital's standard clinical pathway for ACS patients. This includes basic discharge instructions, brochures on heart-healthy lifestyles, and routine outpatient follow-up appointments. No additional structured self-management support or extra telephone follow-ups are provided beyond standard care.
Heart Health Self-Efficacy and Self-Management Scale (HHSES) score
The Heart Health Self-Efficacy and Self-Management Scale (HHSES) is a 12-item instrument assessing participants' self-efficacy and self-management behaviors. Total scores range from 12 (minimum) to 48 (maximum), with higher scores indicating better self-efficacy and self-management. Scores ≥36 indicate high self-efficacy and self-management; 25-35 indicate a moderate level; and ≤24 indicate a low level. Administered at baseline and at 13, 36, and 60 weeks of follow-up.
Time frame: At baseline and at 13, 36, and 60 weeks of follow-up.
Incidence of major adverse cardiovascular events (MACE) including heart failure, angina, arrhythmia, and recurrent myocardial infarction
Major adverse cardiovascular events (MACE) is a composite outcome defined as the occurrence of heart failure, angina, arrhythmia, or recurrent myocardial infarction. Reported as number and proportion of participants experiencing any component event and/or the composite MACE. Assessed from the end of treatment through 60 weeks of follow-up.
Time frame: From the end of treatment through 60 weeks of follow-up
Emergency department visit rate for cardiac-related reasons
Proportion of participants with emergency department visits for cardiac-related reasons during the follow-up period. Calculated as (number of participants with cardiac-related emergency department visits ÷ total number of eligible participants at start of follow-up) × 100%. Assessed from the end of treatment through 60 weeks of follow-up.
Time frame: From the end of treatment through 60 weeks of follow-up
Social Support Rating Scale (SSRS) score
The Social Support Rating Scale (SSRS) is a 10-item instrument assessing social support along three dimensions: objective support, subjective support, and utilization of social support. Total scores range from 13 to 70. Scores \< 33 indicate low social support; 33-45 indicate moderate social support; and \> 45 indicate high social support. Assessed at baseline and at 13, 36, and 60 weeks of follow-up.
Time frame: At baseline and at 13, 36, and 60 weeks of follow-up
Chinese Version of the Brief Illness Perception Questionnaire (BIPQ) score
The Chinese Version of the Brief Illness Perception Questionnaire (BIPQ) is a 9-item instrument measuring illness perception. Total scores range from 0 (minimum) to 80 (maximum), with higher scores indicating worse/more negative illness perception (stronger perceived threat or more negative views toward the illness). Assessed at baseline and at 13, 36, and 60 weeks of follow-up.
Time frame: At baseline and at 13, 36, and 60 weeks of follow-up
Cardiovascular re-hospitalization rate
Proportion of participants re-hospitalized for cardiovascular reasons (e.g., heart failure, angina, arrhythmia, recurrent myocardial infarction) during the 12-month period after the end of treatment. Calculated as (number of participants re-hospitalized for ACS-related cardiovascular reasons during the follow-up period ÷ total number of eligible patients at the start of the follow-up period) × 100%. Assessed from the end of treatment through 60 weeks of follow-up.
Time frame: Assessed from the end of treatment through 60 weeks of follow-up.
Medication Adherence Report Scale (MARS-10) score
The Medication Adherence Report Scale (MARS-10) is a 10-item self-report questionnaire using a dichotomous yes/no response format. It evaluates medication adherence across three dimensions: medication adherence behavior, attitude toward taking medication, and negative side effects and attitudes toward medication. Total scores range from 0 to 10. A score ≤ 5 indicates medication non-adherence, and a score ≥ 6 indicates medication adherence. Assessed at 13, 36, and 60 weeks of follow-up.
Time frame: Assessed at 13, 36, and 60 weeks of follow-up.
Plan to share: Yes — De-identified individual participant data (IPD) including baseline characteristics, intervention implementation data, and primary and secondary outcome measures will be shared. The data sharing plan has been approved by the institutional ethics committee and included in the informed consent process.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will be available starting from 6 months after the publication of the main results and will remain accessible for a period of 3 years.
Access criteria: Access will be granted to qualified researchers (clinicians and nursing scientists) who propose to use the data for legitimate scientific purposes. Interested researchers can submit a data request to the Principal Investigator via email. A data use agreement must be signed prior to data access.
Start is estimated for Sep 2026; primary completion for Dec 2027, 15 months later.
Of 213 non-industry interventional studies with no phase under Acute Coronary Syndrome, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 46. This study's planned 15 months is below that.
Counting every sponsor, half of 228 studies reached it within 34 months; a quarter within 17 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Nanfang Hospital, Southern Medical University →