DiabetesPhase 4ORGANONNCT02935855
ORal anticoaGulants in diAbetic and Nondiabetic Patients With nOn-valvular Atrial fibrillatioN (ORGANON)
A Phase 4 study testing Dabigatran, Apixaban and Rivaroxaban in people with Diabetes, run by University of Pavia at 1 site in Italy.
Trial summary
Diabetic and nondiabetic patients will be evaluated if they had a first diagnosis of non-valvular atrial fibrillation and in therapy with non-vitamin K oral anticoagulants and with vitamin K oral anticoagulants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Dabigatran, Apixaban and Rivaroxaban
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2015to Sep 2019
- 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
- non-valvular atrial fibrillation
- nondiabetic patients
- type 1 and 2 diabetic patients
Who cannot join
- patients with cancer
- patients with chronic inflammation diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Non-vitamin K Oral Anticoagulants and Vitamin K Oral Anticoagulants on Some Metabolic and Coagulation Parameters in Diabetic and Nondiabetic Patients With First Diagnosis of Non-valvular Atrial Fibrillation
Diabetic and nondiabetic patients will be evaluated if they had a first diagnosis of non-valvular atrial fibrillation and in therapy with non-vitamin K oral anticoagulants and with vitamin K oral anticoagulants.
Read the detailed description
Parameters evaluated:
- anthropometric indices
- glycated haemoglobin, basal and postprandial glycemia
- lipid profile
- small and dense LDL; oxidized LDL
- I troponin
- red and white cells count; platelets count
- creatinin, transaminases, iron
- fibrinogen, D-dimer, anti-thrombin III
- Hs-CRP, metalloproteinases 2 and 9
- incidence of bleeding
- Conditions
- Diabetes
- Being tested
- Dabigatran, Apixaban, Rivaroxaban, Edoxaban, Warfarin
- Keywords
- Diabetic patients, nondiabetic patients
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DabigatranDrug
ApixabanDrug
RivaroxabanDrug
EdoxabanDrug
WarfarinDrug
AcenocumaroleDrug
| Study group | Role | What they receive |
|---|---|---|
| Nondiabetics (group 1) | Active comparator | Nondiabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with dabigatran or apixaban or rivaroxaban or edoxaban in randomized way Receives: Drug: Dabigatran; Drug: Apixaban; Drug: Rivaroxaban; Drug: Edoxaban |
| Diabetics (group 1) | Active comparator | Diabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with dabigatran or apixaban or rivaroxaban or edoxaban in randomized way Receives: Drug: Dabigatran; Drug: Apixaban; Drug: Rivaroxaban; Drug: Edoxaban |
| Nondiabetics (group 2) | Active comparator | Nondiabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with warfarin or acenocumarole as guidelines suggest Receives: Drug: Warfarin; Drug: Acenocumarole |
| Diabetics (group 2) | Active comparator | Diabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with warfarin or acenocumarole as guidelines suggest Receives: Drug: Warfarin; Drug: Acenocumarole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy on coagulation parameters
Red cells count
Measured: 12 months
Efficacy on coagulation parameters
Platelets count
Measured: 12 months
Efficacy on coagulation parameters
fibrinogen
Measured: 12 months
Efficacy on coagulation parameters
D-dimer, anti-thrombin III
Measured: 12 months
Secondary outcomes (9)
Bleeding risk
HAS-BLED score
Measured: 12 months
Inflammation parameters
Hs-CRP
Measured: 12 months
Inflammation parameters
White cells count
Measured: 12 months
Endothelial damage
Metalloproteinases 2 and 9
Measured: 12 months
Oxidative status
Small and dense LDL; oxidized LDL
Measured: 12 months
Heart damage
I troponin
Measured: 12 months
Safety and tolerability parameters
Serum creatinin
Measured: 12 months
Safety and tolerability parameters
Serum transaminases
Measured: 12 months
Safety and tolerability parameters
Plasma iron
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startSep 2015
- Primary completionApr 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Derosa, University of Pavia
- Investigators
- Giuseppe Derosa, MD, PhD, FESC, Principal investigator, University of Pavia and IRCCS Policlinico San Matteo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935855
- Sponsor's protocol ID
- 20150003862
- Acronym
- ORGANON
- Status last verified
- Nov 2020
- First submitted
- 1 Oct 2016
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Derosa G, Rizzo M, Brunetti ND, Raddino R, Gavazzoni M, Pasini G, Gaudio G, Maggi A, D'Angelo A, De Gennaro L, Maffioli P. ORal anticoaGulants in diAbetic and Nondiabetic patients with nOn-valvular atrial fibrillatioN (ORGANON). J Diabetes Complications. 2023 Aug;37(8):108512. doi: 10.1016/j.jdiacomp.2023.108512. Epub 2023 May 20.
PubMed 37390799
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Non-vitamin K Oral Anticoagulants and Vitamin K Oral Anticoagulants on Some Metabolic and Coagulation Parameters in Diabetic and Nondiabetic Patients With First Diagnosis of Non-valvular Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02935855
- Acronym / sponsor ID
- ORGANON / 20150003862
- Conditions
- Diabetes
- Keywords
- Diabetic patients, nondiabetic patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Apr 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 18 Oct 2016 (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.
Diabetic and nondiabetic patients will be evaluated if they had a first diagnosis of non-valvular atrial fibrillation and in therapy with non-vitamin K oral anticoagulants and with vitamin K oral anticoagulants.
Detailed description
Parameters evaluated:
- anthropometric indices
- glycated haemoglobin, basal and postprandial glycemia
- lipid profile
- small and dense LDL; oxidized LDL
- I troponin
- red and white cells count; platelets count
- creatinin, transaminases, iron
- fibrinogen, D-dimer, anti-thrombin III
- Hs-CRP, metalloproteinases 2 and 9
- incidence of bleeding
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nondiabetics (group 1) | Active comparator | Drug: Dabigatran, Drug: Apixaban, Drug: Rivaroxaban, Drug: EdoxabanNondiabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with dabigatran or apixaban or rivaroxaban or edoxaban in randomized way |
| Diabetics (group 1) | Active comparator | Drug: Dabigatran, Drug: Apixaban, Drug: Rivaroxaban, Drug: EdoxabanDiabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with dabigatran or apixaban or rivaroxaban or edoxaban in randomized way |
| Nondiabetics (group 2) | Active comparator | Drug: Warfarin, Drug: AcenocumaroleNondiabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with warfarin or acenocumarole as guidelines suggest |
| Diabetics (group 2) | Active comparator | Drug: Warfarin, Drug: AcenocumaroleDiabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with warfarin or acenocumarole as guidelines suggest |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- non-valvular atrial fibrillation
- nondiabetic patients
- type 1 and 2 diabetic patients
Key exclusion criteria (2 listed)
- patients with cancer
- patients with chronic inflammation diseases
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 |
|---|---|---|
| Dabigatran | Drug | Diabetics (group 1), Nondiabetics (group 1) |
| Apixaban | Drug | Diabetics (group 1), Nondiabetics (group 1) |
| Rivaroxaban | Drug | Diabetics (group 1), Nondiabetics (group 1) |
| Edoxaban | Drug | Diabetics (group 1), Nondiabetics (group 1) |
| Warfarin | Drug | Diabetics (group 2), Nondiabetics (group 2) |
| Acenocumarole | Drug | Diabetics (group 2), Nondiabetics (group 2) |
Primary outcome
Efficacy on coagulation parameters
Time frame: 12 months
Red cells count
Efficacy on coagulation parameters
Time frame: 12 months
Platelets count
Efficacy on coagulation parameters
Time frame: 12 months
fibrinogen
Efficacy on coagulation parameters
Time frame: 12 months
D-dimer, anti-thrombin III
9 secondary outcomes
Bleeding risk
Time frame: 12 months
Inflammation parameters
Time frame: 12 months
Inflammation parameters
Time frame: 12 months
Endothelial damage
Time frame: 12 months
Oxidative status
Time frame: 12 months
Heart damage
Time frame: 12 months
Safety and tolerability parameters
Time frame: 12 months
Safety and tolerability parameters
Time frame: 12 months
Safety and tolerability parameters
Time frame: 12 months
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 10 Nov 2020.
- Derived from this study: PubMed 37390799Derosa G, Rizzo M, Brunetti ND, Raddino R, Gavazzoni M, Pasini G, Gaudio G, Maggi A, D'Angelo A, De Gennaro L, Maffioli P. ORal anticoaGulants in diAbetic and Nondiabetic patients with nOn-valvular atrial fibrillatioN (ORGANON). J Diabetes Complications. 2023 Aug;37(8):108512. doi: 10.1016/j.jdiacomp.2023.108512. Epub 2023 May 20.
- 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.
Giuseppe Derosa, MD, PhD, FESC principal investigator
University of Pavia and IRCCS Policlinico San Matteo
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 Dabigatran, Apixaban and Rivaroxaban in people with Diabetes, run by University of Pavia 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 2 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 10 Nov 2020. 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?
Efficacy on coagulation parameters (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02935855, which also lists 1 linked publication.
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 10 Nov 2020.