Diabetes Mellitus, Type 2Phase 4IPADNCT03264352
Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes
A Phase 4 study testing Allisartan Isoproxil, Amlodipine 5mg and Standard treatment by current guideline in people with Diabetes Mellitus, Type 2 and Adverse Event, run by XueQing Yu at 1 site in China.
Trial summary
Lowering of blood pressure (BP) in high-risk hypertensive individuals reduces major adverse cardiovascular and cerebrovascular events. Diabetic patients with hypertension benefit from BP lowering treatment. Read more about this study
- Who is it for?
- Ages 45 to 79 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Adverse Event, Blood Pressure
- What is being tested?
- Allisartan Isoproxil, Amlodipine 5mg and Standard treatment by current guideline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11,414 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2018to 1 Sep 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 45 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- irrespective of sex;
- aged between 45 and 79 years;
- with office-measured seated BP 120-139 mm Hg systolic and below 90 mm Hg diastolic;
- diagnosed of type 2 diabetes mellitus (T2DM), currently on diabetic therapy;
- informed consent provided and long-term follow-up possible
Who cannot join
- poor control of blood glucose, HbA1c > 10.0%
- administration of any antihypertensive medications within 1 month;
- a history of hypoglycemic coma / seizure;
- confirmed diagnosis of type 1 diabetes mellitus;
- alanine-aminotransferase (ALT) or aspartate-aminotransferase (AST) over three times the upper limit of normal;
- estimated glomerular filtration rate < 45 ml/min/1.73m2;
Show all 17Show fewer
- a history of congestive heart failure with left ventricular ejection fraction < 40%;
- coronary artery disease requiring RAS blockers for secondary prevention;
- acute on-set of stroke within 6 months prior to randomization;
- a ratio of urinary albumin (in mg/L) to urinary creatinine (in g/L) (ACR) ≥ 300 mg/g;
- known contraindications for the active study medications;
- a history of psychological or mental disorder;
- pregnancy or currently planning to have babies or lactation;
- severe diseases such as severe heart diseases;
- an expected residual life span less than 3 years;
- a malignancy that clinical investigators consider as unsuitable to participate;
- currently participating in another clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 501080
Yingqing Feng, MD, 86-13602863389, fyq1819@163.com
Qi Zhong, MD, 86-13580366163, zhongqi219@126.com
About this study
Lowering of blood pressure (BP) in high-risk hypertensive individuals reduces major adverse cardiovascular and cerebrovascular events. Diabetic patients with hypertension benefit from BP lowering treatment. The present trial, IPAD in brief, is a randomized, open-label, parallel-designed, multicenter study involving nearly 12,000 patients to be recruited and to be followed up for a median of four years. IPAD tests the hypothesis that antihypertensive medications in adults with type 2 diabetes, whose seated BP 120-139 mm Hg systolic and below 90 mm Hg diastolic, results in 20% difference in the incidence of major adverse cardiovascular and cerebrovascular events. During follow-up for participants in the intensive group, the sitting systolic pressure should be decreased to below 120 mm Hg, by titration and combination of the study medications of an angiotensin type-1 receptor blocker Allisartan (240 mg/day), a dihydropyridine calcium-channel blocker (amlodipine 5-10 mg/day), and/or other medications if necessary. For those in the standard group, the sitting systolic pressure should be monitored and controlled below 140 mm Hg.
Read the detailed description
The IPAD trial is a randomized, open-label, parallel-designed, multicenter study. 11,414 patients will be recruited in three years with a median follow up of four years. IPAD tests the hypothesis that intensive antihypertensive medical therapy in adult patients with type 2 diabetes, whose seated BP ranges from 120 to 139 mm Hg systolic and < 90 mm Hg diastolic, results in 20% reduction in the incidence of major adverse cardiovascular and cerebrovascular events (the primary endpoint), a composite of stroke, cardiovascular death, nonfatal myocardial infarction (MI), hospitalization for heart failure (HF) and hospitalization for unstable angina. Secondary endpoints of this study include: stroke; cardiovascular death; MI; hospitalization for HF; hospitalization for unstable angina; all-cause mortality; overt albuminuria; worsened renal function (the estimated glomerular filtration rate decreased by > 30% from baseline); end-stage renal disease; development of diabetic retinopathy that needs interventional operation; peripheral arterial diseases; new on-set atrial fibrillation or flutter; cancer; decline of health-related quality of life. Inclusion criteria for the study include T2DM patients aged between 45 and 79 years within the aforementioned BP ranges. for participants in the intensive group, the sitting systolic BP should decrease to < 120 mm Hg, using titration and combination of study medications consisting of an angiotensin type-1 receptor blocker Allisartan (240 mg/day) and a dihydropyridine calcium-channel blocker (amlodipine 5-10 mg/day), and/or other medications if necessary.For those in the standard group, the sitting systolic pressure should be monitored and controlled below 140 mm Hg. Across the whole study, 820 primary endpoints are expected to occur. Interim analyses will be carried out on an intention-to-treat basis. At the completion of the trial, both an intention-to-treat and a per-protocol analysis will be performed.
- Conditions
- Diabetes Mellitus, Type 2, Adverse Event, Blood Pressure, Prehypertension, Cardiovascular Risk Factor
- Being tested
- Allisartan Isoproxil, Amlodipine 5mg, Standard treatment by current guideline
- Medical subject headings
- Diabetes Mellitus, Type 2, Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allisartan IsoproxilDrug
Also called Xinlitan
Allisartan Isoproxil 240mg daily will be used to lower BP to below 120 mm Hg systolic.
Amlodipine 5mgDrug
Also called Qiaohean
Amlodipine 5mg daily will be added to Allisartan Isoproxil and afterwards increased to 10mg daily, if necessary to reach the blood pressure goal (below 120 mm Hg systolic).
Standard treatment by current guidelineOther
No BP-lowering medications are used until BP becomes ≥ 140 mm Hg systolic and/or 90 mm Hg diastolic. Medications are determined by investigators in lines with recommendations by current Chinese guidelines to decrease BP to lower than 140 mm Hg systolic and to lower than 90 mm Hg diastolic.
| Study group | Role | What they receive |
|---|---|---|
| intensive treatment group | Active comparator | Real antihypertensive agents will be provided for this arm, to decrease systolic BP to lower than 120 mm Hg. In this group, the following study medications will be used: tablets with Allisartan Isoproxil 240 mg (first-line medication); tablets with Amlodipine 5 mg (second-line medication). Treatment will be started with Allisartan 240 mg. If necessary to reach the BP goal, Amlodipine (first 5 mg or then 10 mg daily) will be given in addition. If intolerable side effects occur, first-line medication may be replaced by second-line medication. Receives: Drug: Allisartan Isoproxil; Drug: Amlodipine 5mg |
| standard treatment group | Placebo comparator | In this arm participants are followed up and no medications be used until BP becomes ≥ 140 mm Hg systolic and/or 90 mm Hg diastolic. Medications are determined by investigators in lines with recommendations by current Chinese guidelines to decrease BP to lower than 140 mm Hg systolic and to lower than 90 mm Hg diastolic. Receives: Other: Standard treatment by current guideline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Major Adverse Cardiovascular and Cerebrovascular Events
The major adverse cardiovascular and cerebrovascular events defined in the study include cardiovascular death, nonfatal stroke, nonfatal myocardial infarction, hospitalization for congestive heart failure and hospitalization for unstable angina.
Measured: From date of randomization until the date of first documented incidence of the major adverse cardiovascular events prespecified, whichever comes first, assessed up to 60 months
Secondary outcomes (14)
Stroke
Stroke (ICD-Code I60, I61, I63, I64) is a focal neurological deficit with symptoms continuing for more than 24 hours or leading to death with no apparent cause other than vascular. Stroke as an endpoint in IPAD includes definite ischemic stroke, primary intracerebral hemorrhage and subarachnoid hemorrhage with evidence from CT or MRI scan within 14 days of onset or autopsy confirmation, and stroke of unknown type etiology when CT, MRI, or autopsy are not done and information is inadequate to diagnose the etiology definitely.
Measured: From date of randomization until the date of first documented incidence of stroke, assessed up to 60 months.
Cardiovascular Death
Cardiovascular death include death caused by stroke, MI, HF, sudden death or any other death attributed to cardiovascular diseases. Sudden death (ICD-Code I46.1, R96) encompasses any death of unknown origin occurring instantly or within an estimated 24 hours after the onset of acute symptoms as well as unattended death for which no likely cause can be established by autopsy or recent medical history.
Measured: From date of randomization until the date of cardiovascular death, assessed up to 60 months.
Acute Myocardial Infarction
Acute myocardial infarction (MI) (ICD-Code I21) is defined when any one of the following criteria occurs. (1) Detection of a rise and/or fall of cardiac biomarker values, with at least one value above the 99th percentile upper reference limit and with at least one of the following manifestations: symptoms of ischaemia that should have lasted for at least 30 minutes and should not have been responsive to sublingual administration of nitrates; new or presumed new significant ST-segment-T wave changes or new left bundle branch block (LBBB); development of pathological Q waves in the ECG; imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. (2) Identification of an intracoronary thrombus by angiography or autopsy. (3) Cardiac death with symptoms suggestive of myocardial ischaemia and presumed new ischaemic ECG changes or new LBBB, but death occurred before cardiac biomarkers were obtained, or before cardiac biomarker values would be increased.
Measured: From date of randomization until the date of first documented incidence of acute MI, assessed up to 60 months.
Hospitalization of Unstable Angina
Unstable angina (ICD-Code I20.0) is defined as new onset or worsening angina pectoris requiring hospitalization with angiographically documented coronary atherosclerosis or transient electrocardiographic changes of the ST-segment or T-wave without evidence for myocardial necrosis. This diagnosis excludes patients with angina pectoris admitted to the hospital only for investigation.
Measured: From date of randomization until the date of first documented hospitalization of unstable angina, assessed up to 60 months.
Hospitalization of Congestive Heart Failure
Congestive heart failure (HF) (ICD-Code I50) requires the presence of three conditions, namely symptoms, such as dyspnea, clinical signs, such as ankle edema or crepitations, and the necessity to initiate treatment with open-label diuretics, vasodilators or antihypertensive drugs. HF cases may also be adjudicated as chronic stable HF but this is not considered an outcome of the present study.
Measured: From date of randomization until the date of first documented hospitalization of HF, assessed up to 60 months.
All-cause Mortality
All-cause mortality refers to death from any causes.
Measured: From date of randomization until the date of death from any causes, assessed up to 60 months.
Overt Albuminuria
Overt albuminuria is defined as a ratio of urinary albumin (in mg/L) to urinary creatinine (in g/L) in urine specimens of at least 300 mg/g.
Measured: From date of randomization until the date of confirmed development of overt albuminuria, assessed up to 60 months.
Worsened Renal Function
Estimated glomerular filtration rate (eGFR) decreased by more than 30% as compared with baseline
Measured: From date of randomization until the date of first documented incidence of this event, assessed up to 60 months.
End-Stage Renal Disease
End-stage renal disease (ICD-Code N18.5) is the need for long-term renal replacement therapy (dialysis).
Measured: From date of randomization until the date of documented diagnosis of end-stage renal disease, assessed up to 60 months.
Diabetic Retinopathy Requiring Interventional Operation or Surgery
Diabetic retinopathy requiring interventional operation or surgery is defined as the confirmed diagnosis of diabetic retinopathy, indicated for interventional operation or surgery, which is documented by ophthalmologists.
Measured: From date of randomization until the date of first documented interventional or surgical operation for diabetic retinopathy, assessed up to 60 months.
Peripheral Arterial Diseases Requiring Revascularization
Peripheral arterial diseases requiring revascularization are defined as the confirmed diagnosis of any one of the peripheral arterial diseases indicated for revascularization.
Measured: From date of randomization until the date of first documented revascularization for peripheral arterial diseases, assessed up to 60 months.
New Atrial Fibrillation or Flutter
Atrial fibrillation or flutter is confirmed and documented with electrocardiogram indicating the occurence of atrial fibrillation or flutter. New development of atrial fibrillation or flutter is defined only if a participant at baseline has no history of and his or her electrocardiogram shows no signs of atrial fibrillation or flutter.
Measured: From date of randomization until the date of first documented incidence of atrial fibrillation or flutter, assessed up to 60 months.
Decline of Health-related Quality of Life
Decline of Health-related Quality of Life, which is assessed using the EQ-5D-5L QOL questionnaire.
Measured: up to 60 months
Cancer
Cancer defined in the present study is recorded only when there is pathologically confirmed evidence.
Measured: From date of randomization until the date of first confirmed diagnosis of a cancer of any type, assessed up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start1 Feb 2018
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11,414 participants (estimated)
Sponsor and investigators
- Lead sponsor
- XueQing Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, XueQing Yu, Guangdong Provincial People's Hospital
- Investigators
- Jiyan Chen, MD, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264352
- Sponsor's protocol ID
- GDREC2017192H
- Acronym
- IPAD
- Status last verified
- Sep 2026
- First submitted
- 21 Aug 2017
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03264352
- Acronym / sponsor ID
- IPAD / GDREC2017192H
- Conditions
- Diabetes Mellitus, Type 2, Adverse Event, Blood Pressure, Prehypertension, Cardiovascular Risk Factor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 11,414 participants (estimated)
- Lead sponsor
- XueQing YuUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 29 Aug 2017 (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.
Lowering of blood pressure (BP) in high-risk hypertensive individuals reduces major adverse cardiovascular and cerebrovascular events. Diabetic patients with hypertension benefit from BP lowering treatment. The present trial, IPAD in brief, is a randomized, open-label, parallel-designed, multicenter study involving nearly 12,000 patients to be recruited and to be followed up for a median of four years. IPAD tests the hypothesis that antihypertensive medications in adults with type 2 diabetes, whose seated BP 120-139 mm Hg systolic and below 90 mm Hg diastolic, results in 20% difference in the incidence of major adverse cardiovascular and cerebrovascular events. During follow-up for participants in the intensive group, the sitting systolic pressure should be decreased to below 120 mm Hg, by titration and combination of the study medications of an angiotensin type-1 receptor blocker Allisartan (240 mg/day), a dihydropyridine calcium-channel blocker (amlodipine 5-10 mg/day), and/or other medications if necessary. For those in the standard group, the sitting systolic pressure should be monitored and controlled below 140 mm Hg.
Detailed description
The IPAD trial is a randomized, open-label, parallel-designed, multicenter study. 11,414 patients will be recruited in three years with a median follow up of four years. IPAD tests the hypothesis that intensive antihypertensive medical therapy in adult patients with type 2 diabetes, whose seated BP ranges from 120 to 139 mm Hg systolic and < 90 mm Hg diastolic, results in 20% reduction in the incidence of major adverse cardiovascular and cerebrovascular events (the primary endpoint), a composite of stroke, cardiovascular death, nonfatal myocardial infarction (MI), hospitalization for heart failure (HF) and hospitalization for unstable angina. Secondary endpoints of this study include: stroke; cardiovascular death; MI; hospitalization for HF; hospitalization for unstable angina; all-cause mortality; overt albuminuria; worsened renal function (the estimated glomerular filtration rate decreased by > 30% from baseline); end-stage renal disease; development of diabetic retinopathy that needs interventional operation; peripheral arterial diseases; new on-set atrial fibrillation or flutter; cancer; decline of health-related quality of life. Inclusion criteria for the study include T2DM patients aged between 45 and 79 years within the aforementioned BP ranges. for participants in the intensive group, the sitting systolic BP should decrease to < 120 mm Hg, using titration and combination of study medications consisting of an angiotensin type-1 receptor blocker Allisartan (240 mg/day) and a dihydropyridine calcium-channel blocker (amlodipine 5-10 mg/day), and/or other medications if necessary.For those in the standard group, the sitting systolic pressure should be monitored and controlled below 140 mm Hg. Across the whole study, 820 primary endpoints are expected to occur. Interim analyses will be carried out on an intention-to-treat basis. At the completion of the trial, both an intention-to-treat and a per-protocol analysis will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intensive treatment group | Active comparator | Drug: Allisartan Isoproxil, Drug: Amlodipine 5mgReal antihypertensive agents will be provided for this arm, to decrease systolic BP to lower than 120 mm Hg. In this group, the following study medications will be used: tablets with Allisartan Isoproxil 240 mg (first-line medication); tablets with Amlodipine 5 mg (second-line medication). Treatment will be started with Allisartan 240 mg. If necessary to reach the BP goal, Amlodipine (first 5 mg or then 10 mg daily) will be given in addition. If intolerable side effects occur, first-line medication may be replaced by second-line medication. |
| standard treatment group | Placebo comparator | Other: Standard treatment by current guidelineIn this arm participants are followed up and no medications be used until BP becomes ≥ 140 mm Hg systolic and/or 90 mm Hg diastolic. Medications are determined by investigators in lines with recommendations by current Chinese guidelines to decrease BP to lower than 140 mm Hg systolic and to lower than 90 mm Hg diastolic. |
Who may qualify
- Ages
- 45 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- irrespective of sex;
- aged between 45 and 79 years;
- with office-measured seated BP 120-139 mm Hg systolic and below 90 mm Hg diastolic;
- diagnosed of type 2 diabetes mellitus (T2DM), currently on diabetic therapy;
- informed consent provided and long-term follow-up possible
Key exclusion criteria (17 listed)
- poor control of blood glucose, HbA1c > 10.0%
- administration of any antihypertensive medications within 1 month;
- a history of hypoglycemic coma / seizure;
- confirmed diagnosis of type 1 diabetes mellitus;
- alanine-aminotransferase (ALT) or aspartate-aminotransferase (AST) over three times the upper limit of normal;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allisartan IsoproxilAlso: XinlitanAllisartan Isoproxil 240mg daily will be used to lower BP to below 120 mm Hg systolic. | Drug | intensive treatment group |
| Amlodipine 5mgAlso: QiaoheanAmlodipine 5mg daily will be added to Allisartan Isoproxil and afterwards increased to 10mg daily, if necessary to reach the blood pressure goal (below 120 mm Hg systolic). | Drug | intensive treatment group |
| Standard treatment by current guidelineNo BP-lowering medications are used until BP becomes ≥ 140 mm Hg systolic and/or 90 mm Hg diastolic. Medications are determined by investigators in lines with recommendations by current Chinese guidelines to decrease BP to lower than 140 mm Hg systolic and to lower than 90 mm Hg diastolic. | Other | standard treatment group |
Primary outcome
Composite of Major Adverse Cardiovascular and Cerebrovascular Events
Time frame: From date of randomization until the date of first documented incidence of the major adverse cardiovascular events prespecified, whichever comes first, assessed up to 60 months
The major adverse cardiovascular and cerebrovascular events defined in the study include cardiovascular death, nonfatal stroke, nonfatal myocardial infarction, hospitalization for congestive heart failure and hospitalization for unstable angina.
14 secondary outcomes
Stroke
Time frame: From date of randomization until the date of first documented incidence of stroke, assessed up to 60 months.
Cardiovascular Death
Time frame: From date of randomization until the date of cardiovascular death, assessed up to 60 months.
Acute Myocardial Infarction
Time frame: From date of randomization until the date of first documented incidence of acute MI, assessed up to 60 months.
Hospitalization of Unstable Angina
Time frame: From date of randomization until the date of first documented hospitalization of unstable angina, assessed up to 60 months.
Hospitalization of Congestive Heart Failure
Time frame: From date of randomization until the date of first documented hospitalization of HF, assessed up to 60 months.
All-cause Mortality
Time frame: From date of randomization until the date of death from any causes, assessed up to 60 months.
Overt Albuminuria
Time frame: From date of randomization until the date of confirmed development of overt albuminuria, assessed up to 60 months.
Worsened Renal Function
Time frame: From date of randomization until the date of first documented incidence of this event, assessed up to 60 months.
End-Stage Renal Disease
Time frame: From date of randomization until the date of documented diagnosis of end-stage renal disease, assessed up to 60 months.
Diabetic Retinopathy Requiring Interventional Operation or Surgery
Time frame: From date of randomization until the date of first documented interventional or surgical operation for diabetic retinopathy, assessed up to 60 months.
Peripheral Arterial Diseases Requiring Revascularization
Time frame: From date of randomization until the date of first documented revascularization for peripheral arterial diseases, assessed up to 60 months.
New Atrial Fibrillation or Flutter
Time frame: From date of randomization until the date of first documented incidence of atrial fibrillation or flutter, assessed up to 60 months.
Decline of Health-related Quality of Life
Time frame: up to 60 months
Cancer
Time frame: From date of randomization until the date of first confirmed diagnosis of a cancer of any type, assessed up to 60 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
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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.
Jiyan Chen, MD principal investigator
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Allisartan Isoproxil, Amlodipine 5mg and Standard treatment by current guideline in people with Diabetes Mellitus, Type 2 and Adverse Event, run by XueQing Yu at 1 site 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 17 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: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiyan Chen, MD (86-13802911148, chen-jiyan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of Major Adverse Cardiovascular and Cerebrovascular Events (time frame: From date of randomization until the date of first documented incidence of the major adverse cardiovascular events prespecified, whichever comes first, assessed up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.