Acute Coronary SyndromePhase 4DIABE-ASACSNCT05293808
Platelet Aggregation in Diabetic Patients With Acute Coronary Syndrome Treated With Different Doses of Aspirin
A Phase 4 study testing aspirin 100 mg bis in die, aspririn 200 mg once daily and aspirin 100 mg once daily in people with Acute Coronary Syndrome and Diabetes Mellitus, run by Federico II University at 1 site in Italy.
Trial summary
Diabetes is an important risk factor of coronary atherosclerosis, and it's well known that platelets of diabetic patients are hyper reactive and so resistant to common antithrombotic therapy. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome, Diabetes Mellitus
- What is being tested?
- aspirin 100 mg bis in die, aspririn 200 mg once daily and aspirin 100 mg once daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2014to 1 Jan 2016
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic patients with acute coronary syndrome after 24 hours from the coronarography
Who cannot join
- patients with a family or personal history of bleeding or thrombophilic disorders;
- platelet count >600000/mmc or <150000/mmc
- hematocrit >50% or <25%
- creatinine clearance <30 mL/min
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Different Doses of Aspirin on Platelet Aggregation in Diabetic Patients With Acute Coronary Syndrome
Diabetes is an important risk factor of coronary atherosclerosis, and it's well known that platelets of diabetic patients are hyper reactive and so resistant to common antithrombotic therapy. Moreover, in diabetic patients platelets are characterized by high turnover that is responsible of lack of protection by cardioaspirin at common dosage. The aim of our study is to asses the efficacy of different doses of aspirin in diabetic patients with acute coronary syndrome.
- Conditions
- Acute Coronary Syndrome, Diabetes Mellitus
- Being tested
- aspirin 100 mg bis in die, aspririn 200 mg once daily, aspirin 100 mg once daily
- Keywords
- platelet aggregation, acute coronary syndrome, diabetes
- Medical subject headings
- Acute Coronary Syndrome, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirin 100 mg bis in dieDrug
Patient will be randomized and after 10 days and 30 days we will measure platelets aggregation.
aspririn 200 mg once dailyDrug
Patient will be randomized and after 10 days and 30 days we will measure platelets aggregation.
aspirin 100 mg once dailyDrug
Patient will be randomized and after 10 days and 30 days we will measure platelets aggregation.
| Study group | Role | What they receive |
|---|---|---|
| aspirin 100 mg bis in die | Experimental | aspirin 100 mg twice daily for the first month after acute coronary syndrome Receives: Drug: aspirin 100 mg bis in die |
| aspirin 200 mg | Active comparator | aspirin 200 mg once daily for the first month after acute coronary syndrome Receives: Drug: aspririn 200 mg once daily |
| aspririn 100 mg | Active comparator | aspirin 100 mg once daily Receives: Drug: aspirin 100 mg once daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of different doses of aspirin on platelet aggregation
Valuation of different doses of aspirin once or twice daily on platelet aggregation after 10 day and 30 day from the acute coronary syndrome
Measured: 1 month
Secondary outcomes (1)
Valuation of RAC1 levels in platelets
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start1 May 2014
- Primary completion1 Oct 2014
- Study completion1 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Federico II 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Esposito, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293808
- Sponsor's protocol ID
- 8/14
- Acronym
- DIABE-ASACS
- Status last verified
- Feb 2024
- First submitted
- 15 Mar 2022
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Doses of Aspirin on Platelet Aggregation in Diabetic Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT05293808
- Acronym / sponsor ID
- DIABE-ASACS / 8/14
- Conditions
- Acute Coronary Syndrome, Diabetes Mellitus
- Keywords
- platelet aggregation, acute coronary syndrome, diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 May 2014 (actual)
- Primary completion
- 1 Oct 2014 (actual)
- Study completion
- 1 Jan 2016 (actual)
- First posted
- 24 Mar 2022 (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.
Diabetes is an important risk factor of coronary atherosclerosis, and it's well known that platelets of diabetic patients are hyper reactive and so resistant to common antithrombotic therapy. Moreover, in diabetic patients platelets are characterized by high turnover that is responsible of lack of protection by cardioaspirin at common dosage. The aim of our study is to asses the efficacy of different doses of aspirin in diabetic patients with acute coronary syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| aspirin 100 mg bis in die | Experimental | Drug: aspirin 100 mg bis in dieaspirin 100 mg twice daily for the first month after acute coronary syndrome |
| aspirin 200 mg | Active comparator | Drug: aspririn 200 mg once dailyaspirin 200 mg once daily for the first month after acute coronary syndrome |
| aspririn 100 mg | Active comparator | Drug: aspirin 100 mg once dailyaspirin 100 mg once daily |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetic patients with acute coronary syndrome after 24 hours from the coronarography
Key exclusion criteria (4 listed)
- patients with a family or personal history of bleeding or thrombophilic disorders;
- platelet count >600000/mmc or <150000/mmc
- hematocrit >50% or <25%
- creatinine clearance <30 mL/min
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 100 mg bis in diePatient will be randomized and after 10 days and 30 days we will measure platelets aggregation. | Drug | aspirin 100 mg bis in die |
| aspririn 200 mg once dailyPatient will be randomized and after 10 days and 30 days we will measure platelets aggregation. | Drug | aspirin 200 mg |
| aspirin 100 mg once dailyPatient will be randomized and after 10 days and 30 days we will measure platelets aggregation. | Drug | aspririn 100 mg |
Primary outcome
Effects of different doses of aspirin on platelet aggregation
Time frame: 1 month
Valuation of different doses of aspirin once or twice daily on platelet aggregation after 10 day and 30 day from the acute coronary syndrome
1 secondary outcome
Valuation of RAC1 levels in platelets
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 100 mg bis in die, aspririn 200 mg once daily and aspirin 100 mg once daily in people with Acute Coronary Syndrome and Diabetes Mellitus, run by Federico II University at 1 site in Italy.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 23 Feb 2024. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effects of different doses of aspirin on platelet aggregation (time frame: 1 month). 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 23 Feb 2024.