Diabetes Mellitus Type IIPhase 4VERDINCT01684813
VERifynow in DIabetes Non-responsiveness: a Study on Switching From Clopidogrel to Prasugrel
A Phase 4 study testing Prasugrel. and Clopidogrel in people with Diabetes Mellitus Type II and Acute Coronary Syndrome, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial summary
The purpose of this study is to determine if, in type 2 diabetic patients undergoing treatment with PCI and a stent, who fail to respond to normal doses of clopidogrel, a loading dose of 60 mg of prasugrel followed by 10 mg once daily is superior to the standard dose of 75 mg of clopidogrel in achieving greater than… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus Type II, Acute Coronary Syndrome
- What is being tested?
- Prasugrel. and Clopidogrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2012to Oct 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetic patients with acute coronary syndrome with non-ST segment elevation who are undergoing a percutaneous coronary intervention (PCI) with a coronary stent.
- Patients who are non-responsive on the platelet anti-aggregation test with standard doses of clopidogrel will be randomized.
- Participants must sign an informed consent document.
Who cannot join
- Age <18 years or >80 years.
- Patients with acute coronary syndrome with ST segment elevation.
- Pregnancy previous to or during the study.
- The use of oral anticoagulants in the last 10 days with an INR >1.5 or who plan to use them during the follow-up period (1 year).
- Antithrombotic treatment with GP IIb/IIIa inhibitors.
- Contraindication for the use of prasugrel and/or clopidogrel and/or aspirin:
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- Antecedents of pharmacologic allergy to thienopyridine derivatives or aspirin.
- Antecedents of clinically significant or persistent thrombocytopenia or neutropenia.
- Active bleeding or significant increase of risk of hemorrhage such as severe hepatic insufficiency, peptic ulcer present, proliferative diabetic retinopathy, antecedents of severe systemic bleeding, gastrointestinal bleeding, macrohematuria, intraocular hemorrhage, hemorrhagic stroke, or intracranial bleeding), or other antecedents of bleeding diathesis or coagulopathy.
- Patients with previous TIA or CVA.
- Patients weighing <60 Kg.
- Hemoglobin <10.5 g/dl, or Hematocrit <30%.
- Severe left ventricular systolic dysfunction, EF <35%.
- Renal insufficiency with creatinine levels >2 mg/dl.
- Previous inclusion of the patient in another study.
- Treatment in research (medication or device) in the last 30 days prior.
- Medical, geographical, or social factors that would make participation in the study impractical, such as the incapacity to provide written informed consent and to understand the complete meaning of informed consent, or the refusal of the patient to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study With Loading Dose of Prasugrel Opposed to the Standard Dose of Clopidogrel in Type 2 Diabetic Patients in Acute Coronary Syndrome, Revascularized Through Drug-eluting Stent.
The purpose of this study is to determine if, in type 2 diabetic patients undergoing treatment with PCI and a stent, who fail to respond to normal doses of clopidogrel, a loading dose of 60 mg of prasugrel followed by 10 mg once daily is superior to the standard dose of 75 mg of clopidogrel in achieving greater than 50% inhibition of platelet aggregation at 24-36 hours of treatment.
Read the detailed description
The VERDI study consists on a randomized, mono-center study comparing the treatment plan of a loading dose of prasugrel as opposed to the standard dose in type 2 diabetic patients, who suffer acute coronary syndrome, revascularized through an invasive percutaneous strategy with a stent. The aim of this study is to determine if, in type 2 diabetic patients undergoing treatment with PCI and a stent, who fail to respond to normal doses of clopidogrel, a loading dose of 60 mg of prasugrel followed by 10 mg once daily is superior to the standard dose of 75 mg of clopidogrel in achieving greater than 50% inhibition of platelet aggregation at 24-36 hours of treatment.
- Conditions
- Diabetes Mellitus Type II, Acute Coronary Syndrome
- Being tested
- Prasugrel., Clopidogrel
- Keywords
- Diabetes mellitus., Acute coronary syndrome., Percutaneous coronary intervention.
- Medical subject headings
- Diabetes Mellitus, Type 2, Acute Coronary Syndrome, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prasugrel.Drug
Also called Efient, Eli Lilly
Patients in this group will receive a loading dose of 60 mg prasugrel (6 x 10 mg tablets) followed by at least dose of 10 mg prasugrel (1 x 10 mg tablet). Beyond the second day after PCI, these patients will receive double antiaggregation therapy according to their physician´s criteria.
ClopidogrelDrug
Also called Agrelan
Patients in this group will receive the standard dose of clopidogrel, a daily dose of 75 mg. Beyond the second day post-PCI, these patients will receive double anti aggregation therapy according to their physician's criteria.
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel | Active comparator | This group will receive after PCI the standard dose of clopidogrel, a daily dose of 75 mg. Receives: Drug: Clopidogrel |
| Prasugrel | Experimental | This group will receive after PCI a loading dose of 60 mg prasugrel (6 x 10 mg tablets) followed by a daily dose of prasugrel (10 mg tablet). Receives: Drug: Prasugrel. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who achieve inhibition of platelet aggregation greater that 50%
The principal objective is to determine whether in type 2 diabetic patients who are non-responsive to clopidogrel at habitual doses and who receive treatment through percutaneous coronary intervention (PCI) with a stent, a treatment plan with a loading dose of prasugrel (60 mg) followed by 1 cp (10 mg) once a day, is superior to a standard dose of 75 mg clopidogrel in achieving greater than 50% inhibition of platelet aggregation at 24-36 hours of treatment.
Measured: 24 to 36 hours post-PCI
Secondary outcomes (3)
Number of participants with adverse events as a measure of safety and tolerability
To evaluate the safety of treatment with prasugrel in comparison with the standard treatment with clopidogrel in terms of the appearance of secondary effects (severe bleeding, thrombocytopenia, neutropenia, gastrointestinal changes, thrombotic thrombocytopenic purpura).
Measured: 30 days
Number of patients who die or present the combined endpoint of cardiovascular death, MI or recurrent ischemia as a measure of efficacy.
To assess the results in different sub-groups and analyze the combined endpoint of cardiovascular death, MI or recurrent ischemia at 30 days.
Measured: 30 days.
Number of participants who are non-responsiveness to antiaggregation therapy as a measure of efficacy
To analyze the characteristics of patients who are non-responsive to anti-aggregation therapy.
Measured: 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2013
- Study completionOct 2013
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 Diabetes Mellitus Type IIStudies 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
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Collaborators
- Andaluz Health Service
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684813
- Sponsor's protocol ID
- VERDI study
- Acronym
- VERDI
- Status last verified
- Sep 2014
- First submitted
- 11 Sep 2012
- Last updated
- 22 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Cubero Gomez JM, Acosta Martinez J, Mendias Benitez C, Diaz De La Llera LS, Fernandez-Quero M, Guisado Rasco A, Villa Gil-Ortega M, Sanchez Gonzalez A. VERifyNow in DIabetes high-on-treatment platelet reactivity: a pharmacodynamic study on switching from clopidogrel to prasugrel. Acta Cardiol. 2015 Dec;70(6):728-34. doi: 10.2143/AC.70.6.3120187.
PubMed 26717223
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study With Loading Dose of Prasugrel Opposed to the Standard Dose of Clopidogrel in Type 2 Diabetic Patients in Acute Coronary Syndrome, Revascularized Through Drug-eluting Stent.
- ClinicalTrials.gov ID
- NCT01684813
- Acronym / sponsor ID
- VERDI / VERDI study
- Conditions
- Diabetes Mellitus Type II, Acute Coronary Syndrome
- Keywords
- Diabetes mellitus., Acute coronary syndrome., Percutaneous coronary intervention.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Collaborators
- Andaluz Health Service
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 13 Sep 2012 (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 purpose of this study is to determine if, in type 2 diabetic patients undergoing treatment with PCI and a stent, who fail to respond to normal doses of clopidogrel, a loading dose of 60 mg of prasugrel followed by 10 mg once daily is superior to the standard dose of 75 mg of clopidogrel in achieving greater than 50% inhibition of platelet aggregation at 24-36 hours of treatment.
Detailed description
The VERDI study consists on a randomized, mono-center study comparing the treatment plan of a loading dose of prasugrel as opposed to the standard dose in type 2 diabetic patients, who suffer acute coronary syndrome, revascularized through an invasive percutaneous strategy with a stent. The aim of this study is to determine if, in type 2 diabetic patients undergoing treatment with PCI and a stent, who fail to respond to normal doses of clopidogrel, a loading dose of 60 mg of prasugrel followed by 10 mg once daily is superior to the standard dose of 75 mg of clopidogrel in achieving greater than 50% inhibition of platelet aggregation at 24-36 hours of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel | Active comparator | Drug: ClopidogrelThis group will receive after PCI the standard dose of clopidogrel, a daily dose of 75 mg. |
| Prasugrel | Experimental | Drug: Prasugrel.This group will receive after PCI a loading dose of 60 mg prasugrel (6 x 10 mg tablets) followed by a daily dose of prasugrel (10 mg tablet). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetic patients with acute coronary syndrome with non-ST segment elevation who are undergoing a percutaneous coronary intervention (PCI) with a coronary stent.
- Patients who are non-responsive on the platelet anti-aggregation test with standard doses of clopidogrel will be randomized.
- Participants must sign an informed consent document.
Key exclusion criteria (17 listed)
- Age <18 years or >80 years.
- Patients with acute coronary syndrome with ST segment elevation.
- Pregnancy previous to or during the study.
- The use of oral anticoagulants in the last 10 days with an INR >1.5 or who plan to use them during the follow-up period (1 year).
- Antithrombotic treatment with GP IIb/IIIa inhibitors.
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 |
|---|---|---|
| Prasugrel.Also: Efient, Eli LillyPatients in this group will receive a loading dose of 60 mg prasugrel (6 x 10 mg tablets) followed by at least dose of 10 mg prasugrel (1 x 10 mg tablet). Beyond the second day after PCI, these patients will receive double antiaggregation therapy according to their physician´s criteria. | Drug | Prasugrel |
| ClopidogrelAlso: AgrelanPatients in this group will receive the standard dose of clopidogrel, a daily dose of 75 mg. Beyond the second day post-PCI, these patients will receive double anti aggregation therapy according to their physician's criteria. | Drug | Clopidogrel |
Primary outcome
Number of patients who achieve inhibition of platelet aggregation greater that 50%
Time frame: 24 to 36 hours post-PCI
The principal objective is to determine whether in type 2 diabetic patients who are non-responsive to clopidogrel at habitual doses and who receive treatment through percutaneous coronary intervention (PCI) with a stent, a treatment plan with a loading dose of prasugrel (60 mg) followed by 1 cp (10 mg) once a day, is superior to a standard dose of 75 mg clopidogrel in achieving greater than 50% inhibition of platelet aggregation at 24-36 hours of treatment.
3 secondary outcomes
Number of participants with adverse events as a measure of safety and tolerability
Time frame: 30 days
Number of patients who die or present the combined endpoint of cardiovascular death, MI or recurrent ischemia as a measure of efficacy.
Time frame: 30 days.
Number of participants who are non-responsiveness to antiaggregation therapy as a measure of efficacy
Time frame: 30 days.
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 22 Sep 2014.
- Derived from this study: PubMed 26717223Cubero Gomez JM, Acosta Martinez J, Mendias Benitez C, Diaz De La Llera LS, Fernandez-Quero M, Guisado Rasco A, Villa Gil-Ortega M, Sanchez Gonzalez A. VERifyNow in DIabetes high-on-treatment platelet reactivity: a pharmacodynamic study on switching from clopidogrel to prasugrel. Acta Cardiol. 2015 Dec;70(6):728-34. doi: 10.2143/AC.70.6.3120187.
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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 Prasugrel. and Clopidogrel in people with Diabetes Mellitus Type II and Acute Coronary Syndrome, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
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 17 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 22 Sep 2014. 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 Spain. 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?
Number of patients who achieve inhibition of platelet aggregation greater that 50% (time frame: 24 to 36 hours post-PCI). 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 NCT01684813, 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 22 Sep 2014.