Aspirin ResistancePhase 4ARRDMNCT01935193
Aspirin Resistance Reversibility in Diabetic Patients
A Phase 4 study testing lysine acetylsalicylate in people with Aspirin Resistance, run by Azienda Ospedaliera San Giovanni Battista at 1 site in Italy.
Trial summary
The aim of the study is assessing the prevalence of aspirin resistance in a cohort of diabetic patients. Those found resistant has been undergone pharmacological tests using different drug formulations to investigate the reversibility of aspirin resistance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aspirin Resistance
- What is being tested?
- lysine acetylsalicylate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2011to Aug 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diabete mellitus type 2
- asa since 30 days at least
- plts >150000 and <450000
Who cannot join
- recent ACS (within 30 days)
- anticoagulant therapy
- haemorragic diathesis
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
San Giovanni Battista Hospital
Torino
Marta Bisi, MD, +393476985414, martadoro@hotmail.com
About this study
Official title: Impact of Different Pharmacological Formulations on Aspirin Resistance Reversibility in Diabetics Patients
The aim of the study is assessing the prevalence of aspirin resistance in a cohort of diabetic patients. Those found resistant has been undergone pharmacological tests using different drug formulations to investigate the reversibility of aspirin resistance.
- Conditions
- Aspirin Resistance
- Being tested
- lysine acetylsalicylate
- Keywords
- platelets aggregation, asa resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lysine acetylsalicylateDrug
Also called Flectadol, Cardirene
| Study group | Role | What they receive |
|---|---|---|
| asa resistant | Experimental | asa resistant patients receive endovenous infusion of lysine acetylsalicylate 288 mg and if asa resistance has been reversed they have been prescribed oral soluble salt of lysine acetylsalicylate. Receives: Drug: lysine acetylsalicylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
platelets aggregation assessed by two tests (PFA100 and VerifyNow)
diabetic patients found aspirin resistant receive and infusion of 288 mg of lysine acetylsalicylate and they are tested again 24 h after the infusion to investigate if aspirin resistance have been reversed.
Measured: 24 hours
Secondary outcomes (1)
stability of aggregation state after the reversion of aspirin resistance using oral formulation of lysine acetylsalicylate
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 posted5 Sep 2013 (estimated)
- Study startNov 2011
- Primary completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspirin ResistanceStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera San Giovanni Battista
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Bisi, Azienda Ospedaliera San Giovanni Battista
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935193
- Sponsor's protocol ID
- ASAR160
- Acronym
- ARRDM
- Status last verified
- Aug 2013
- First submitted
- 28 Aug 2013
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Different Pharmacological Formulations on Aspirin Resistance Reversibility in Diabetics Patients
- ClinicalTrials.gov ID
- NCT01935193
- Acronym / sponsor ID
- ARRDM / ASAR160
- Conditions
- Aspirin Resistance
- Keywords
- platelets aggregation, asa resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera San Giovanni BattistaUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Aug 2013 (actual)
- First posted
- 5 Sep 2013 (estimated)
- 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.
The aim of the study is assessing the prevalence of aspirin resistance in a cohort of diabetic patients. Those found resistant has been undergone pharmacological tests using different drug formulations to investigate the reversibility of aspirin resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| asa resistant | Experimental | Drug: lysine acetylsalicylateasa resistant patients receive endovenous infusion of lysine acetylsalicylate 288 mg and if asa resistance has been reversed they have been prescribed oral soluble salt of lysine acetylsalicylate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diabete mellitus type 2
- asa since 30 days at least
- plts >150000 and <450000
Key exclusion criteria (3 listed)
- recent ACS (within 30 days)
- anticoagulant therapy
- haemorragic diathesis
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 |
|---|---|---|
| lysine acetylsalicylateAlso: Flectadol, Cardirene | Drug | asa resistant |
Primary outcome
platelets aggregation assessed by two tests (PFA100 and VerifyNow)
Time frame: 24 hours
diabetic patients found aspirin resistant receive and infusion of 288 mg of lysine acetylsalicylate and they are tested again 24 h after the infusion to investigate if aspirin resistance have been reversed.
1 secondary outcome
stability of aggregation state after the reversion of aspirin resistance using oral formulation of lysine acetylsalicylate
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
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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 lysine acetylsalicylate in people with Aspirin Resistance, run by Azienda Ospedaliera San Giovanni Battista 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 3 inclusion and 3 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 5 Sep 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marta Bisi, MD (+393476985414, martadoro@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
platelets aggregation assessed by two tests (PFA100 and VerifyNow) (time frame: 24 hours). 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 5 Sep 2013.