Stable Coronary Heart DiseaseNCT04308551
Effect of Indobufen and Aspirin on Platelet Aggregation and Long Term Prognosis in Patients With Coronary Heart Disease
A study testing Indobufen and Aspirin in people with Stable Coronary Heart Disease, run by Henan Institute of Cardiovascular Epidemiology.
Trial summary
This study evaluates the effect of Indobufen and Aspirin on platelet aggregation and long term prognosis in patients with stable coronary heart disease. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stable Coronary Heart Disease
- What is being tested?
- Indobufen and Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2024to 30 Dec 2026
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years < age ≤ 85 years;
- Patients with confirmed stable coronary heart disease (must meet at least one of the following conditions);
- 2.1 a stenosis confirmed by Coronary angiography or dual-source CT, but the stenosis of the Left Main Artery (LMA) diameter is less than 50%, the stenosis of the left anterior descending branch（LAD）is less than 70%, and the stenosis of the two or three coronary arteries diameter is less than 70%, patient has no corresponding evidence of ischemia;
- 2.2 Patients after percutaneous coronary intervention (PCI): Dual antiplatelet therapy (DAPT) time is greater than 9 months, without cardiovascular events and ischemic symptoms; and currently receiving aspirin 100 mg/d with clopidogrel 75 mg/d or ticagrelor 90mg (bid) dual antiplatelet therapy.
- 2.3 Patients after coronary artery bypass graft (CABG): Dual antiplatelet therapy (DAPT) time is greater than 9 months, without cardiovascular events and ischemic symptoms; and currently receiving aspirin 100 mg/d with clopidogrel 75 mg/d or ticagrelor 90mg (bid) dual antiplatelet therapy.
- Willing to sign the informed consent.
Who cannot join
- Acute coronary syndrome (ACS) occurred within 3 months before screening;
- Percutaneous coronary intervention or CABG surgery within 9 months before screening;
- Any other conditions (such as atrial fibrillation, pulmonary embolism, lower extremity venous thrombosis, artificial heart valve, etc.) who need oral or intravenous anticoagulation treatment;
- In the past 3 months, the Arachidonic acid-induced platelet aggregation rate≥ 50%; inhibition rate ≤ 20% in the aspirin combined with clopidogrel treated patients;
- Congestive heart failure or left ventricular ejection fraction <35%;
- A positive history of Chronic Obstructive Pulmonary Disease (COPD);
Show all 16Show fewer
- bleeding tendency or severe lung disease;
- Active pathological bleeding;
- History of intracranial hemorrhage (less than 3 months);
- Allergic to indobufen / aspirin (or any of its ingredients);
- Severe liver injury (transaminases exceeding the upper limit of 2 times and above);
- Pregnancy, lactation and those who have a birth plan;
- Hematological diseases, platelet count <100000 / mm3 or hemoglobin <10g / dL;
- Have a history of drug or alcohol abuse in the past 2 years;
- Use of non-steroidal anti-inflammatory drugs (within 3 months);
- Creatinine clearance <30ml/min;
About this study
Official title: Effect of Indobufen and Aspirin on Platelet Aggregation and Long Term Prognosis in Patients With Stable Coronary Heart Disease. A Prospective, Randomized and Controlled，Single Blind, Single-center, Opening Study
This study evaluates the effect of Indobufen and Aspirin on platelet aggregation and long term prognosis in patients with stable coronary heart disease.
- Conditions
- Stable Coronary Heart Disease
- Being tested
- Indobufen, Aspirin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IndobufenDrug
Indobufen Tablets
AspirinDrug
Aspirin Tablets
| Study group | Role | What they receive |
|---|---|---|
| Indobufen | Experimental | 200 mg Indobufen, bid po, 90 days Receives: Drug: Indobufen |
| Aspirin | Active comparator | 100 mg Aspirin, qd po, 90 days Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates 7 days after taking the Indobufen or Aspirin
Patients with stable coronary heart disease were treated with Indobufen or Aspirin for 90 days. Subsequently, the investigators used the Light transmission aggregation(LTA) and Thrombelastography (TEG) methods to detect the Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates on the 7 days.
Measured: 7 days
Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates 30 days after taking the Indobufen or Aspirin
Patients with stable coronary heart disease were treated with Indobufen or Aspirin for 90 days. Subsequently, the investigators used the Light transmission aggregation(LTA) and Thrombelastography (TEG) methods to detect the Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates on the 30 days.
Measured: 30 days
Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates 90 days after taking the Indobufen or Aspirin
Patients with stable coronary heart disease were treated with Indobufen or Aspirin for 90 days. Subsequently, the investigators used the Light transmission aggregation(LTA) and Thrombelastography (TEG) methods to detect the Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates on the 90 days.
Measured: 90 days
Concentration of Thromboxane B2 (TXB2) at baseline
The fasting blood was collected after the subjects signed informed consent；And the concentration of TXB2 was detected by enzyme-linked immuno sorbent assay (ELISA)
Measured: baseline
Concentration of Thromboxane B2 (TXB2) 7 days after taking the Indobufen or Aspirin
The fasting blood was collected 7 days after taking the Indobufen or Aspirin；And the concentration of TXB2 was detected by enzyme-linked immuno sorbent assay (ELISA)
Measured: 7 days
Concentration of Thromboxane B2 (TXB2) 30 days after taking the Indobufen or Aspirin
The fasting blood was collected 30 days after taking the Indobufen or Aspirin；And the concentration of TXB2 was detected by enzyme-linked immuno sorbent assay (ELISA)
Measured: 30 days
Concentration of Thromboxane B2 (TXB2) 90 days after taking the Indobufen or Aspirin
The fasting blood was collected 90 days after taking the Indobufen or Aspirin；And the concentration of TXB2 was detected by enzyme-linked immuno sorbent assay (ELISA)
Measured: 90 days
Secondary outcomes (5)
Incidence of Bleeding
During the study period, we used dual occult blood and questionnaire format to assess whether the subject experienced bleeding (the extent and location of the bleeding) and the degree of bleeding related to indobufen or aspirin (Certainly, likely, possible, suspicious, impossible)
Measured: baseline, 7, 30 and 90 days
Incidence of Adverse Gastrointestinal reaction
During the study period, we used dual occult blood and questionnaire format to assess whether the subject experienced adverse gastrointestinal reaction, such as nausea, vomiting, upper abdominal discomfort or pain, gastric mucosal damage, gastric ulcers and bleeding, etc
Measured: 7, 30 and 90 days
Blood concentration
The fasting blood was collected on the day of 7 days, 30 days, and 90 days；And the blood concentration of aspirin or indobufen or clopidogrel or ticagrelor was detected.
Measured: 7, 30 and 90 days
Cyclooxygenase-1 gene phenotype
The fasting blood was collected and saved on the day of enrollment, and then the gene phenotype of cyclooxygenase-1 would be detected, and their relationship with platelet aggregation also would be analyzed.
Measured: baseline
Major adverse cardiovascular events
Number of angina pectoris symptoms, non ST-segment elevation myocardial infarction (NSTEMI), ST-segment elevation myocardial infarction (STEMI), stroke, cardiovascular death, cerebrovascular death, all-cause death
Measured: 7, 30 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start30 Dec 2024 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Why it stopped: shortage of funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable Coronary Heart DiseaseStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Institute of Cardiovascular Epidemiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- chuanyu gao, MD, Principal investigator, central china fuwai hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308551
- Sponsor's protocol ID
- HenanICE202001
- Status last verified
- Nov 2024
- First submitted
- 6 Mar 2020
- Last updated
- 20 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Indobufen and Aspirin on Platelet Aggregation and Long Term Prognosis in Patients With Stable Coronary Heart Disease. A Prospective, Randomized and Controlled，Single Blind, Single-center, Opening Study
- ClinicalTrials.gov ID
- NCT04308551
- Acronym / sponsor ID
- HenanICE202001
- Conditions
- Stable Coronary Heart Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: shortage of funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henan Institute of Cardiovascular EpidemiologyUniversity, hospital or other
- Study start
- 30 Dec 2024 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 16 Mar 2020 (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.
This study evaluates the effect of Indobufen and Aspirin on platelet aggregation and long term prognosis in patients with stable coronary heart disease.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indobufen | Experimental | Drug: Indobufen200 mg Indobufen, bid po, 90 days |
| Aspirin | Active comparator | Drug: Aspirin100 mg Aspirin, qd po, 90 days |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years < age ≤ 85 years;
- Patients with confirmed stable coronary heart disease (must meet at least one of the following conditions);
- 2.1 a stenosis confirmed by Coronary angiography or dual-source CT, but the stenosis of the Left Main Artery (LMA) diameter is less than 50%, the stenosis of the left anterior descending branch（LAD）is less than 70%, and the stenosis of the two or three coronary arteries diameter is less than 70%, patient has no corresponding evidence of ischemia;
- 2.2 Patients after percutaneous coronary intervention (PCI): Dual antiplatelet therapy (DAPT) time is greater than 9 months, without cardiovascular events and ischemic symptoms; and currently receiving aspirin 100 mg/d with clopidogrel 75 mg/d or ticagrelor 90mg (bid) dual antiplatelet therapy.
- 2.3 Patients after coronary artery bypass graft (CABG): Dual antiplatelet therapy (DAPT) time is greater than 9 months, without cardiovascular events and ischemic symptoms; and currently receiving aspirin 100 mg/d with clopidogrel 75 mg/d or ticagrelor 90mg (bid) dual antiplatelet therapy.
Key exclusion criteria (16 listed)
- Acute coronary syndrome (ACS) occurred within 3 months before screening;
- Percutaneous coronary intervention or CABG surgery within 9 months before screening;
- Any other conditions (such as atrial fibrillation, pulmonary embolism, lower extremity venous thrombosis, artificial heart valve, etc.) who need oral or intravenous anticoagulation treatment;
- In the past 3 months, the Arachidonic acid-induced platelet aggregation rate≥ 50%; inhibition rate ≤ 20% in the aspirin combined with clopidogrel treated patients;
- Congestive heart failure or left ventricular ejection fraction <35%;
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 |
|---|---|---|
| IndobufenIndobufen Tablets | Drug | Indobufen |
| AspirinAspirin Tablets | Drug | Aspirin |
Primary outcome
Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates 7 days after taking the Indobufen or Aspirin
Time frame: 7 days
Patients with stable coronary heart disease were treated with Indobufen or Aspirin for 90 days. Subsequently, the investigators used the Light transmission aggregation(LTA) and Thrombelastography (TEG) methods to detect the Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates on the 7 days.
Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates 30 days after taking the Indobufen or Aspirin
Time frame: 30 days
Patients with stable coronary heart disease were treated with Indobufen or Aspirin for 90 days. Subsequently, the investigators used the Light transmission aggregation(LTA) and Thrombelastography (TEG) methods to detect the Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates on the 30 days.
Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates 90 days after taking the Indobufen or Aspirin
Time frame: 90 days
Patients with stable coronary heart disease were treated with Indobufen or Aspirin for 90 days. Subsequently, the investigators used the Light transmission aggregation(LTA) and Thrombelastography (TEG) methods to detect the Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates on the 90 days.
Concentration of Thromboxane B2 (TXB2) at baseline
Time frame: baseline
The fasting blood was collected after the subjects signed informed consent；And the concentration of TXB2 was detected by enzyme-linked immuno sorbent assay (ELISA)
Concentration of Thromboxane B2 (TXB2) 7 days after taking the Indobufen or Aspirin
Time frame: 7 days
The fasting blood was collected 7 days after taking the Indobufen or Aspirin；And the concentration of TXB2 was detected by enzyme-linked immuno sorbent assay (ELISA)
Concentration of Thromboxane B2 (TXB2) 30 days after taking the Indobufen or Aspirin
Time frame: 30 days
The fasting blood was collected 30 days after taking the Indobufen or Aspirin；And the concentration of TXB2 was detected by enzyme-linked immuno sorbent assay (ELISA)
Concentration of Thromboxane B2 (TXB2) 90 days after taking the Indobufen or Aspirin
Time frame: 90 days
The fasting blood was collected 90 days after taking the Indobufen or Aspirin；And the concentration of TXB2 was detected by enzyme-linked immuno sorbent assay (ELISA)
5 secondary outcomes
Incidence of Bleeding
Time frame: baseline, 7, 30 and 90 days
Incidence of Adverse Gastrointestinal reaction
Time frame: 7, 30 and 90 days
Blood concentration
Time frame: 7, 30 and 90 days
Cyclooxygenase-1 gene phenotype
Time frame: baseline
Major adverse cardiovascular events
Time frame: 7, 30 and 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No
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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.
chuanyu gao, MD principal investigator
central china fuwai hospital
Questions about this trial
What is this clinical trial studying?
A study testing Indobufen and Aspirin in people with Stable Coronary Heart Disease, run by Henan Institute of Cardiovascular Epidemiology.
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 6 inclusion and 16 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: withdrawn, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates 7 days after taking the Indobufen or Aspirin (time frame: 7 days). The study lists 7 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 20 Nov 2024.