A Phase 4 interventional study of Clopidogrel and Clopidogrel+aspirin in Prolonged DAPT in ACS Patients With Hisk of Both Ischemic and Hemorrhage, sponsored by Shenyang Northern Hospital. Completed at 103 sites in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-08-21.
Sponsored by Shenyang Northern Hospital · Phase 4, Interventional, and Treatment
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Among 97 studies in Hemorrhage with a site in China — 27 open to participants now, 29 under way, 5 of them phase 3. Hemorrhage · China.
Among the 97 studies in Hemorrhage with a site in China, this one has the largest enrollment of the 77 interventional ones that give a count, is one of 8 that started in 2018, is one of 14 in phase 4, and was the 41st registered.
1,383 studies on the registry are indexed under Hemorrhage; 244 are open to participants now.
Browse Hemorrhage studies →27 of the 97 studies in Hemorrhage with a site in China are open now. Recruiting first, the newest first:
Second Affiliated Hospital, Zhejiang University, School of Medicine · Sites in China
Ages 18–80
Sun Yat-sen University · Sites in China
Ages 18–75
Guangdong Provincial People's Hospital · Sites in China
Ages 75+
Xijing Hospital of Digestive Diseases · Sites in China
Ages 18–75
Jilin University · Sites in China
Ages 18–85
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 170 Hemorrhage studies recruiting now, 109 (64%) set no upper age limit and 40 (24%) stop at 75 or younger; 25 take children under 18; 21 take healthy volunteers.
This study: 18 Years to 85 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.
97 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 4 · Phase 2 5 · Phase 3 17 · Phase 4 14
First in 2003; this study’s year is marked. 8 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 7,758 is above the median of 102 across 926 interventional studies indexed under Hemorrhage.
Median enrollment 200 across the 77 interventional studies, 341 across the 20 observational. Of the 39 that completed or were terminated, 6 (15%) have results posted.
This tab as a report to print or save as PDF → With an account.
11 of 97 have an industry lead sponsor. The 10 most frequent:
Shenyang Northern Hospital is the lead sponsor of 42 studies on the registry; 11 are open to participants now.
Shenyang Northern Hospital has 1 study filed under Hemorrhage — fewer than ten, so there is no comparison to draw.
11 of the studies in Hemorrhage with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07129031Phase 3Xijing HospitalOptimization Strategies for Blood Transfusion Protocols in the Emergency Treatment of Hemorrhagic Shock | 2027-06-30 |
| NCT05764356Peking University First HospitalImapct of bioMarkers on Pharmacodynamics and Bleeding Risk of Direct Oral AntiCoagulants and Ticagrelor Study II | 2026-12 |
| NCT07617428Lanzhou University Second HospitalClinical Validation of a Blood Loss Monitoring System | 2026-12-30 |
| NCT07653945First Affiliated Hospital of Ningbo UniversityRed Dichromatic Imaging for Improving Post-Biopsy Bronchoscopic Field Visibility | 2026-12-31 |
| NCT07311343Beijing Tiantan HospitalOral Hygiene and Prophylactic Antibiotics to Prevent Intracerebral Hemorrhage Associated Pneumonia | 2026-12-31 |
Add all 11 to your calendar (.ics) → With an account.
Among the 97 studies in Hemorrhage with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Current guidelines recommend that patients with ACS undergoing stent implantation might be offered extended DAPT treatment for up to 30 months if necessary.
Therefore, we designed a prospective, multicenter, randomized, placebo-controlled trial among ACS patients with high-risk on ischemic and bleeding who received a new generation of DES and received 9 to 12 months of DAPT, and evaluated whether clopidogrel monotherapy reduce the risk of bleeding compared with clopidogrel plus ASA in the following 9 months and achieved non-inferior outcomes in preventing ischemic risk.
Current guidelines recommend that patients with ACS undergoing stent implantation might be offered extended DAPT treatment for up to 30 months if necessary. For patients with high risk of both ischemic and hemorrhage, despite prolonged use of DAPT may bring antithrombotic benefit, it may also increase the risk of bleeding. There is an urgent need for specific guiding on intensive antiplatelet therapy in this population of patients to reduce the risk of ischemia and to avoid the risk of bleeding.
Previous studies have shown that, after 12 months of DAPT treatment, continuation of clopidogrel monotherapy may further reduce the risk of ischemia and bleeding compared with aspirin. Therefore, we designed a prospective, multicenter, randomized, placebo-controlled trial among ACS patients with high-risk on ischemic and bleeding who received a new generation of DES and received 9 to 12 months of DAPT, and evaluated whether clopidogrel monotherapy reduce the risk of bleeding compared with clopidogrel plus ASA in the following 9 months and achieved non-inferior outcomes in preventing ischemic risk.
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.
Clinical criteria of high bleeding risk:
Clinical criteria of high ischemic risk:
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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On the basis of 9-12 months of DAPT(aspirin+clopidogrel), continue clopidogrel monotherapy in the following 9 months.
Drug: Clopidogrel
On the basis of 9-12 months of DAPT(aspirin+clopidogrel), continue DAPT (aspirin+clopidogrel) in the following 9 months.
Drug: Clopidogrel+aspirin
Additional 9 months of clopidogrel monotherapy after 9-12 months of DAPT (aspirin+clopidogrel)
Drug pages: Clopidogrel · Aspirin
Additional 9 months of clopidogrel plus aspirin after 9-12 months of DAPT (aspirin+clopidogrel)
Clinical relevant bleeding events
defined as BARC type 2-5 bleeding events
Time frame: During 9-month follow up
All bleeding events
defined all BARC type 1-5 bleeding events
Time frame: During 9-month follow up
Major adverse cardiovascular and cerebrovascular events(MACCE)
defined as a composite endpoints of all-cause death, myofarction, stroke and clinically indicated revascularization
Time frame: During 9-month follow up
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Plan to share: No
Ran from Feb 2018 to primary completion in Dec 2020, 34 months.
Of 92 non-industry phase 4 interventional studies under Hemorrhage, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 58. This study's 34 months is above that.
Counting every sponsor, half of 96 studies reached it within 28 months; a quarter within 18 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Clopidogrel
Shenyang Northern Hospital