Diabetes Mellitus Type 2 Platelets Reactivity StatinPhase 4NCT03195153
Effect of Allopurinol on Mono and Co-administration With Statins on Platelets Reactivity on Diabetic Patiets Treated With Aspirin and Insulin
A Phase 4 study testing Atorvastatin 80mg, ALLOPURINOL 300 MG and Atorvastatin 80mg AND allopurinol 300 mg in people with Diabetes Mellitus Type 2 Platelets Reactivity Statin, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Diabetes mellitus is associated with an increased risk of cardiovascular disease. Substantial clinical and experimental evidence suggest that both diabetes and insulin resistance cause a combination of endothelial dysfunctions, which may diminish the anti-atherogenic role of the vascular endothelium. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Type 2 Platelets Reactivity Statin
- What is being tested?
- Atorvastatin 80mg, ALLOPURINOL 300 MG and Atorvastatin 80mg AND allopurinol 300 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 28 Mar 2017to 15 Jul 2017
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diabetic patient;
- therapy with aspirin and insulin;
- patient well responders
Who cannot join
- not diabetic patient;
- patients in dual antiplatelet therapy;
- patient with severe renal failure;
- patient poor responders
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Policlinico Umberto I
Rome, Roma, 00155
MARINA MD POLACCO, 3333347960, POLAMARI@LIBERO.IT
About this study
Diabetes mellitus is associated with an increased risk of cardiovascular disease. Substantial clinical and experimental evidence suggest that both diabetes and insulin resistance cause a combination of endothelial dysfunctions, which may diminish the anti-atherogenic role of the vascular endothelium. Therefore, in patients with diabetes or insulin resistance, endothelial dysfunction may be a critical early target for preventing atherosclerosis and cardiovascular disease. It has been implicated as an independent risk factor for cardiovascular disease and premature cardiovascular mortality for patients with type 1 and type 2 diabetes mellitus, as well as for patients with essential hypertension. A complete biochemical understanding of the mechanisms by which hyperglycemia causes vascular functional and structural changes associated with the diabetic milieu still eludes us. In recent years, the numerous biochemical and metabolic pathways postulated to have a causal role in the pathogenesis of diabetic vascular disease have been distilled into several unifying hypotheses. The role of chronic hyperglycemia in the development of diabetic microvascular complications and in neuropathy has been clearly established. However, the biochemical or cellular links between elevated blood glucose levels, and the vascular lesions remain incompletely understood. A number of trials have demonstrated that statins therapy as well as angiotensin converting enzyme inhibitors is associated with improvements in endothelial function in diabetes. Although antioxidants provide short-term improvement of endothelial function in humans, all studies of the effectiveness of preventive antioxidant therapy have been disappointing. Actually, control of hyperglycemia thus remains the best way to improve endothelial function and to prevent atherosclerosis and other cardiovascular complications of diabetes.
- Being tested
- Atorvastatin 80mg, ALLOPURINOL 300 MG, Atorvastatin 80mg AND allopurinol 300 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 80mgDrug
30 DAYS OF atorvastatin 80 mg
ALLOPURINOL 300 MGDrug
30 DAYS OF ALLOPURINOL 300 MG
Atorvastatin 80mg AND allopurinol 300 mgDrug
30 days of atorvastatin and allopurinol 300 mg
| Study group | Role | What they receive |
|---|---|---|
| statin only | Experimental | 30 DAYS OF STATIN THERAPY ATORVASTATIN 80 MG) Receives: Drug: Atorvastatin 80mg |
| allopurinol only | Experimental | 30 DAYS OF ALLOPURINOL (300 MG) Receives: Drug: ALLOPURINOL 300 MG |
| statin and allopurinol | Experimental | 30 DAYS OF CO-ADMINISTRATION OF ATORVASTATIN AND ALLOPURINOL Receives: Drug: Atorvastatin 80mg AND allopurinol 300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of platelet reaction units Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay [Accumetrics, San Diego, California] After 30 days of treatment with each drug
Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay [Accumetrics, San Diego, California]
Measured: fter 30 days of treatment with each drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start28 Mar 2017
- Primary completion23 Jun 2017 (estimated)
- Study completion15 Jul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2 Platelets Reactivity StatinStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Polacco Marina, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195153
- Sponsor's protocol ID
- UNIVERSITY OF ROME
- Status last verified
- Jun 2017
- First submitted
- 28 May 2017
- Last updated
- 22 Jun 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 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Allopurinol on Mono and Co-administration With Statins on Platelets Reactivity on Diabetic Patiets Treated With Aspirin and Insulin
- ClinicalTrials.gov ID
- NCT03195153
- Acronym / sponsor ID
- UNIVERSITY OF ROME
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 23 Jun 2017 (estimated)
- Study completion
- 15 Jul 2017 (estimated)
- First posted
- 22 Jun 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.
Diabetes mellitus is associated with an increased risk of cardiovascular disease. Substantial clinical and experimental evidence suggest that both diabetes and insulin resistance cause a combination of endothelial dysfunctions, which may diminish the anti-atherogenic role of the vascular endothelium. Therefore, in patients with diabetes or insulin resistance, endothelial dysfunction may be a critical early target for preventing atherosclerosis and cardiovascular disease. It has been implicated as an independent risk factor for cardiovascular disease and premature cardiovascular mortality for patients with type 1 and type 2 diabetes mellitus, as well as for patients with essential hypertension. A complete biochemical understanding of the mechanisms by which hyperglycemia causes vascular functional and structural changes associated with the diabetic milieu still eludes us. In recent years, the numerous biochemical and metabolic pathways postulated to have a causal role in the pathogenesis of diabetic vascular disease have been distilled into several unifying hypotheses. The role of chronic hyperglycemia in the development of diabetic microvascular complications and in neuropathy has been clearly established. However, the biochemical or cellular links between elevated blood glucose levels, and the vascular lesions remain incompletely understood. A number of trials have demonstrated that statins therapy as well as angiotensin converting enzyme inhibitors is associated with improvements in endothelial function in diabetes. Although antioxidants provide short-term improvement of endothelial function in humans, all studies of the effectiveness of preventive antioxidant therapy have been disappointing. Actually, control of hyperglycemia thus remains the best way to improve endothelial function and to prevent atherosclerosis and other cardiovascular complications of diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| statin only | Experimental | Drug: Atorvastatin 80mg30 DAYS OF STATIN THERAPY ATORVASTATIN 80 MG) |
| allopurinol only | Experimental | Drug: ALLOPURINOL 300 MG30 DAYS OF ALLOPURINOL (300 MG) |
| statin and allopurinol | Experimental | Drug: Atorvastatin 80mg AND allopurinol 300 mg30 DAYS OF CO-ADMINISTRATION OF ATORVASTATIN AND ALLOPURINOL |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diabetic patient;
- therapy with aspirin and insulin;
- patient well responders
Key exclusion criteria (4 listed)
- not diabetic patient;
- patients in dual antiplatelet therapy;
- patient with severe renal failure;
- patient poor responders
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 |
|---|---|---|
| Atorvastatin 80mg30 DAYS OF atorvastatin 80 mg | Drug | statin only |
| ALLOPURINOL 300 MG30 DAYS OF ALLOPURINOL 300 MG | Drug | allopurinol only |
| Atorvastatin 80mg AND allopurinol 300 mg30 days of atorvastatin and allopurinol 300 mg | Drug | statin and allopurinol |
Primary outcome
Assessment of platelet reaction units Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay [Accumetrics, San Diego, California] After 30 days of treatment with each drug
Time frame: fter 30 days of treatment with each drug
Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay [Accumetrics, San Diego, California]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
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 Atorvastatin 80mg, ALLOPURINOL 300 MG and Atorvastatin 80mg AND allopurinol 300 mg in people with Diabetes Mellitus Type 2 Platelets Reactivity Statin, run by University of Roma La Sapienza 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 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: status not confirmed, as of the sponsor's last update on 22 Jun 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 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 marina mp polacco (3333347960, polamari@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of platelet reaction units Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay [Accumetrics, San Diego, California] After 30 days of treatment with each drug (time frame: fter 30 days of treatment with each drug). 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 22 Jun 2017.