Coronary AtherosclerosisPhase 4NCT03230851
the Efficacy and Safety of Indobufen and Low-dose Aspirin in Different Regimens of Antiplatelet Therapy
A Phase 4 study testing aspirin 100mg/d therapy, aspirin 100mg/2d therapy and aspirin 100mg/3d therapy in people with Coronary Atherosclerosis, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
A total of 210 coronary atherosclerosis patients without indications for stent implantation are included. The baseline values of platelet aggregation rate, plasmaThromboxaneB2 and urinary 11-dh ThromboxaneB2 are measured by Light Transmittance Aggregometry method and ELISA after aspirin 100 mg /d ≥5d. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Atherosclerosis
- What is being tested?
- aspirin 100mg/d therapy, aspirin 100mg/2d therapy and aspirin 100mg/3d therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2017to 10 Aug 2018
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of coronary atherosclerosis without indications for stent implantation .
- Patient aged >18 years and ≤75years. Must be able to swallow tablets
Who cannot join
- Aspirin resistance; uncontrolled hypertension (> 160 / 100mmHg); hemoglobin <100g / L; hemorrhagic disease or bleeding tendency history; taking other non-steroidal drugs; severe liver disease history; malignant neoplasms; active gastric mucosa bleeding; PCI history; coronary artery bypass surgery; cardiac function grade Ⅳ.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
A total of 210 coronary atherosclerosis patients without indications for stent implantation are included. The baseline values of platelet aggregation rate, plasmaThromboxaneB2 and urinary 11-dh ThromboxaneB2 are measured by Light Transmittance Aggregometry method and ELISA after aspirin 100 mg /d ≥5d. Then the patients are randomly divided into 7 groups: Group1: aspirin 100 mg/d; Group2: aspirin 100 mg /2d; Groups3: aspirin 100 mg / 3d; Groups4: morning 50mg evening 50mg; Group5: aspirin 75mg / d; Group6: aspirin 50mg / d; Group7: indobufen100mg bid. One month later,arachidonic acid-induced platelet aggregation rate , plasma TXB2 and urine 11-dh TXB2 are analyzed again. All patients are followed-up for 1 year. The stomach Intestinal reactions, small bleeding events are recorded.
Read the detailed description
A total of 210 coronary atherosclerosis patients without indications for stent implantation are included. Exclusion criteria：Aspirin resistance, uncontrolled hypertension (> 160 / 100mmHg),hemoglobin concentration <100g /L, hemorrhagic disease or a history of bleeding tendency, taking other nonsteroidal drugs, severe liver disease history, malignant tumor, active gastric mucosa bleeding, percutaneous coronary intervention history, coronary artery bypass surgery, cardiac function grade Ⅳ.The baseline values of platelet aggregation rate, plasma TXB2 and urinary 11-dh TXB2 are measured by LTA method and ELISA after aspirin 100 mg /d ≥5d. Then the patients are randomly divided into 7 groups: Group1: aspirin 100 mg/d; Group2: aspirin 100 mg /2d; Groups3: aspirin 100 mg / 3d; Groups4: morning 50mg evening 50mg; Group5: aspirin 75mg / d; Group6: aspirin 50mg / d; Group7: indobufen100mg bid. One month later,arachidonic acid-induced platelet aggregation rate , plasma TXB2 and urine 11-dh TXB2 are analyzed again. All patients are followed-up for 1month,6months and1 year. The stomach Intestinal reactions, small bleeding events ,whether to take proton pump inhibitors are recorded.
- Conditions
- Coronary Atherosclerosis
- Being tested
- aspirin 100mg/d therapy, aspirin 100mg/2d therapy, aspirin 100mg/3d therapy, aspirin 50mg bid therapy, aspirin 75mg/d therapy
- Keywords
- Light Transmittance Aggregometry, Indobufen, Aspirin, Plasma Thromboxane, Urine 11-dehydro thromboxane
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirin 100mg/d therapyDrug
100mg aspirin for at least 5 days followed by aspirin 100mg/d
aspirin 100mg/2d therapyDrug
100mg aspirin for at least 5 days followed by aspirin 100mg/2d
aspirin 100mg/3d therapyDrug
100mg aspirin for at least 5 days followed by aspirin 100mg/3d
aspirin 50mg bid therapyDrug
100mg aspirin for at least 5 days followed by aspirin 50mg bid
aspirin 75mg/d therapyDrug
100mg aspirin for at least 5 days followed by aspirin 75mg/d
aspirin 50mg/d therapyDrug
100mg aspirin for at least 5 days followed by aspirin 50mg/d
indobufen 100mg bid therapyDrug
100mg aspirin for at least 5 days followed by indobufen 100mg bid
| Study group | Role | What they receive |
|---|---|---|
| aspirin 100mg/d therapy | Experimental | Group1: aspirin 100 mg/d; Receives: Drug: aspirin 100mg/d therapy |
| aspirin 100mg/2d therapy | Experimental | Group2: aspirin ; Receives: Drug: aspirin 100mg/2d therapy |
| aspirin 100mg/3d therapy | Experimental | Groups3: aspirin ; Receives: Drug: aspirin 100mg/3d therapy |
| aspirin 50mg bid therapy | Experimental | Groups4: morning 50mg evening 50mg; Receives: Drug: aspirin 50mg bid therapy |
| aspirin 75mg/d therapy | Experimental | Group5: aspirin 75mg / d; Receives: Drug: aspirin 75mg/d therapy |
| aspirin 50mg/d therapy | Experimental | Group6: aspirin 50mg / d; Receives: Drug: aspirin 50mg/d therapy |
| indobufen 100mg bid therapy | Experimental | Group7: 100mg bid Receives: Drug: indobufen 100mg bid therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
platelet aggregation
Regional differences between blood samples from each subjects of different groups by LTA.The results of LTA are reported in platelet aggregation rate(%).Platelet aggregation was induced by0.5mg/ml arachidonic acid (AA).
Measured: 2 hours
plasma thromboxaneB2
The plasma thromboxane B2 concentration of each subjects are measured by enzyme-linked immunosorbent assay .(cayman chemical, thromboxaneB2 express EIA kit-Monoclonal)
Measured: 3montshs
urine 11-dehydro thromboxaneB2
The urine 11-dehydro thromboxane B2 concentration of each subjects are measured by ELISA.(cayman chemical,11-dehydro thromboxaneB2 ELISA kit-Monoclonal)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start20 Aug 2017 (estimated)
- Primary completion10 Jul 2018 (estimated)
- Study completion10 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary AtherosclerosisStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunjian Li, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230851
- Sponsor's protocol ID
- 006
- Status last verified
- Jul 2017
- First submitted
- 24 Jul 2017
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Efficacy and Safety of Indobufen and Low-dose Aspirin in Different Regimens of Antiplatelet Therapy
- ClinicalTrials.gov ID
- NCT03230851
- Acronym / sponsor ID
- 006
- Conditions
- Coronary Atherosclerosis
- Keywords
- Light Transmittance Aggregometry, Indobufen, Aspirin, Plasma Thromboxane, Urine 11-dehydro thromboxane
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 20 Aug 2017 (estimated)
- Primary completion
- 10 Jul 2018 (estimated)
- Study completion
- 10 Aug 2018 (estimated)
- First posted
- 27 Jul 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.
A total of 210 coronary atherosclerosis patients without indications for stent implantation are included. The baseline values of platelet aggregation rate, plasmaThromboxaneB2 and urinary 11-dh ThromboxaneB2 are measured by Light Transmittance Aggregometry method and ELISA after aspirin 100 mg /d ≥5d. Then the patients are randomly divided into 7 groups: Group1: aspirin 100 mg/d; Group2: aspirin 100 mg /2d; Groups3: aspirin 100 mg / 3d; Groups4: morning 50mg evening 50mg; Group5: aspirin 75mg / d; Group6: aspirin 50mg / d; Group7: indobufen100mg bid. One month later,arachidonic acid-induced platelet aggregation rate , plasma TXB2 and urine 11-dh TXB2 are analyzed again. All patients are followed-up for 1 year. The stomach Intestinal reactions, small bleeding events are recorded.
Detailed description
A total of 210 coronary atherosclerosis patients without indications for stent implantation are included. Exclusion criteria：Aspirin resistance, uncontrolled hypertension (> 160 / 100mmHg),hemoglobin concentration <100g /L, hemorrhagic disease or a history of bleeding tendency, taking other nonsteroidal drugs, severe liver disease history, malignant tumor, active gastric mucosa bleeding, percutaneous coronary intervention history, coronary artery bypass surgery, cardiac function grade Ⅳ.The baseline values of platelet aggregation rate, plasma TXB2 and urinary 11-dh TXB2 are measured by LTA method and ELISA after aspirin 100 mg /d ≥5d. Then the patients are randomly divided into 7 groups: Group1: aspirin 100 mg/d; Group2: aspirin 100 mg /2d; Groups3: aspirin 100 mg / 3d; Groups4: morning 50mg evening 50mg; Group5: aspirin 75mg / d; Group6: aspirin 50mg / d; Group7: indobufen100mg bid. One month later,arachidonic acid-induced platelet aggregation rate , plasma TXB2 and urine 11-dh TXB2 are analyzed again. All patients are followed-up for 1month,6months and1 year. The stomach Intestinal reactions, small bleeding events ,whether to take proton pump inhibitors are recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| aspirin 100mg/d therapy | Experimental | Drug: aspirin 100mg/d therapyGroup1: aspirin 100 mg/d; |
| aspirin 100mg/2d therapy | Experimental | Drug: aspirin 100mg/2d therapyGroup2: aspirin ; |
| aspirin 100mg/3d therapy | Experimental | Drug: aspirin 100mg/3d therapyGroups3: aspirin ; |
| aspirin 50mg bid therapy | Experimental | Drug: aspirin 50mg bid therapyGroups4: morning 50mg evening 50mg; |
| aspirin 75mg/d therapy | Experimental | Drug: aspirin 75mg/d therapyGroup5: aspirin 75mg / d; |
| aspirin 50mg/d therapy | Experimental | Drug: aspirin 50mg/d therapyGroup6: aspirin 50mg / d; |
| indobufen 100mg bid therapy | Experimental | Drug: indobufen 100mg bid therapyGroup7: 100mg bid |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of coronary atherosclerosis without indications for stent implantation .
- Patient aged >18 years and ≤75years. Must be able to swallow tablets
Key exclusion criteria (1 listed)
- Aspirin resistance; uncontrolled hypertension (> 160 / 100mmHg); hemoglobin <100g / L; hemorrhagic disease or bleeding tendency history; taking other non-steroidal drugs; severe liver disease history; malignant neoplasms; active gastric mucosa bleeding; PCI history; coronary artery bypass surgery; cardiac function grade Ⅳ.
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 |
|---|---|---|
| aspirin 100mg/d therapy100mg aspirin for at least 5 days followed by aspirin 100mg/d | Drug | aspirin 100mg/d therapy |
| aspirin 100mg/2d therapy100mg aspirin for at least 5 days followed by aspirin 100mg/2d | Drug | aspirin 100mg/2d therapy |
| aspirin 100mg/3d therapy100mg aspirin for at least 5 days followed by aspirin 100mg/3d | Drug | aspirin 100mg/3d therapy |
| aspirin 50mg bid therapy100mg aspirin for at least 5 days followed by aspirin 50mg bid | Drug | aspirin 50mg bid therapy |
| aspirin 75mg/d therapy100mg aspirin for at least 5 days followed by aspirin 75mg/d | Drug | aspirin 75mg/d therapy |
| aspirin 50mg/d therapy100mg aspirin for at least 5 days followed by aspirin 50mg/d | Drug | aspirin 50mg/d therapy |
| indobufen 100mg bid therapy100mg aspirin for at least 5 days followed by indobufen 100mg bid | Drug | indobufen 100mg bid therapy |
Primary outcome
platelet aggregation
Time frame: 2 hours
Regional differences between blood samples from each subjects of different groups by LTA.The results of LTA are reported in platelet aggregation rate(%).Platelet aggregation was induced by0.5mg/ml arachidonic acid (AA).
plasma thromboxaneB2
Time frame: 3montshs
The plasma thromboxane B2 concentration of each subjects are measured by enzyme-linked immunosorbent assay .(cayman chemical, thromboxaneB2 express EIA kit-Monoclonal)
urine 11-dehydro thromboxaneB2
Time frame: 3 months
The urine 11-dehydro thromboxane B2 concentration of each subjects are measured by ELISA.(cayman chemical,11-dehydro thromboxaneB2 ELISA kit-Monoclonal)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
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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.
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 aspirin 100mg/d therapy, aspirin 100mg/2d therapy and aspirin 100mg/3d therapy in people with Coronary Atherosclerosis, run by The First Affiliated Hospital with Nanjing Medical University 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 31 Jul 2017. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Chunjian, Ph.D (+86-25-83718836 ext. 6018, lijay@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
platelet aggregation (time frame: 2 hours). The study lists 3 primary outcomes in all. 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 31 Jul 2017.