AtherosclerosisPhase 4PRIMARIANCT00734123
Early Detection of Atherosclerosis: a Randomized Trial in the Primary Prevention of Cardiovascular Diseases.
A Phase 4 study testing Simvastatin or Atorvastatin, Enalapril and Aspirin or clopidogrel in people with Atherosclerosis and Cardiovascular Diseases, run by Hospital Arnau de Vilanova at 1 site in Spain.
Trial summary
The incidence of cardiovascular diseases is still high and further efforts should be done in primary prevention. The main objective is to quantify the burden of subclinical atherosclerosis using non-invasive techniques,and to study the impact of this assessment and consequent treatment in the progression of… Read more about this study
- Who is it for?
- Ages 40 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Cardiovascular Diseases
- What is being tested?
- Simvastatin or Atorvastatin, Enalapril and Aspirin or clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,948 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2008to May 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 40 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- One or more of the following:
- Familiar History of early-onset cardiovascular disease (male < 55 or female < 65).
- Type 2 Diabetes mellitus or type 1 with microalbuminuria.
- Essential High Blood Pressure.
- Chronic Kidney Disease.
- Primary hyperlipidemia.
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- The presence of two or more of the following:
- Current smoker.
- Physical inactivity.
- High blood pressure (recently diagnosed).
- Abdominal perimeter: > 102 cm. males; > 88 cm. females.
- Total cholesterol > 240 mg/dL.
- HDL cholesterol ≤ 40 mg/dL males, ≤ 50 mg/dL females.
Who cannot join
- Age < 40 or > 74 years old.
- Previous Cardiovascular Event.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Arnau de Vilanova
Lleida, Catalonia, 25260
Blai Coll, MD,PhD, +34 619633249, bcoll@arnau.scs.es
Blai Coll, MD,PhD
About this study
Official title: Early Detection of Atherosclerosis in the Primary Care Setting: a Randomized Trial to Assess the Efficacy of a Novel Strategy in the Primary Prevention of Cardiovascular Diseases.
The incidence of cardiovascular diseases is still high and further efforts should be done in primary prevention. The main objective is to quantify the burden of subclinical atherosclerosis using non-invasive techniques,and to study the impact of this assessment and consequent treatment in the progression of atherosclerosis and in the incidence of cardiovascular diseases.
Read the detailed description
We will perform non-invasive techniques (carotid Intima-Media Thickness, CAC score and ankle-brachial index) to individuals at intermediate cardiovascular risk.With these results, we will classify participants in: no atherosclerosis, mild, moderate and severe atherosclerosis, and therapeutic targets will be set according to pre-defined algorithms. The end-point will be the course of atherosclerosis measured by cIMT/CAC score (2 years) and the incidence of CVD at 5 years of follow-up.
- Conditions
- Atherosclerosis, Cardiovascular Diseases
- Being tested
- Simvastatin or Atorvastatin, Enalapril, Aspirin or clopidogrel, Rimonabant
- Keywords
- Atherosclerosis, Cardiovascular Prevention, Carotid Intima-Media Thickness, Ankle-Brachial Index
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simvastatin or AtorvastatinDrug
Also called Simvastatin 10-40., Atorvastatin 20-40.
Simvastatin 10-40 mg or Atorvastatin 20-40 mg will be prescribed according to LDL cholesterol reduction target.
EnalaprilDrug
Also called ACE inhibitors., ACE + diuretic
Enalapril 10 mg/day will be prescribed as the initial treatment. Doses and adding drugs will be titrated accordingly
Aspirin or clopidogrelDrug
Also called Antiplatelets
Aspirin 100 mg or clopidogrel 75 mg/ per day
RimonabantDrug
Also called Rimonabant is allowed.
In both arms, we will follow the standard clinical care in terms of treatments, as far as obesity and diabetes mellitus is concerned.
Drugs will be prescribed as the standard clinical care
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants assigned to the intensive arm (1) will be targeted to specified therapeutic aims (concerning lipids, blood pressure and antiplatelets)according to the results of carotid ultrasound and ankle-brachial index. Receives: Drug: Simvastatin or Atorvastatin; Drug: Enalapril; Drug: Aspirin or clopidogrel; Drug: Rimonabant |
| 2 | Active comparator | Participants assigned to control group (2) will be followed according to the clinical standard of care. Receives: Drug: Rimonabant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid Intima-Media Thickness progression/regression
Measured: 2 years
Secondary outcomes (1)
Cardio and cerebrovascular eventS
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2009 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,948 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Arnau de Vilanova
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Elvira Fernandez, MD,PhD, Principal investigator, Hospital Arnau de Vilanova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734123
- Sponsor's protocol ID
- UDETMA_08
- Other IDs
- UDETMA_2008_001
- Acronym
- PRIMARIA
- Status last verified
- Aug 2008
- First submitted
- 11 Aug 2008
- Last updated
- 14 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Atherosclerosis in the Primary Care Setting: a Randomized Trial to Assess the Efficacy of a Novel Strategy in the Primary Prevention of Cardiovascular Diseases.
- ClinicalTrials.gov ID
- NCT00734123
- Acronym / sponsor ID
- PRIMARIA / UDETMA_08
- Conditions
- Atherosclerosis, Cardiovascular Diseases
- Keywords
- Atherosclerosis, Cardiovascular Prevention, Carotid Intima-Media Thickness, Ankle-Brachial Index
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,948 participants (estimated)
- Lead sponsor
- Hospital Arnau de VilanovaUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Apr 2008
- Primary completion
- Apr 2009 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 14 Aug 2008 (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 incidence of cardiovascular diseases is still high and further efforts should be done in primary prevention. The main objective is to quantify the burden of subclinical atherosclerosis using non-invasive techniques,and to study the impact of this assessment and consequent treatment in the progression of atherosclerosis and in the incidence of cardiovascular diseases.
Detailed description
We will perform non-invasive techniques (carotid Intima-Media Thickness, CAC score and ankle-brachial index) to individuals at intermediate cardiovascular risk.With these results, we will classify participants in: no atherosclerosis, mild, moderate and severe atherosclerosis, and therapeutic targets will be set according to pre-defined algorithms. The end-point will be the course of atherosclerosis measured by cIMT/CAC score (2 years) and the incidence of CVD at 5 years of follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Simvastatin or Atorvastatin, Drug: Enalapril, Drug: Aspirin or clopidogrel, Drug: RimonabantParticipants assigned to the intensive arm (1) will be targeted to specified therapeutic aims (concerning lipids, blood pressure and antiplatelets)according to the results of carotid ultrasound and ankle-brachial index. |
| 2 | Active comparator | Drug: RimonabantParticipants assigned to control group (2) will be followed according to the clinical standard of care. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Familiar History of early-onset cardiovascular disease (male < 55 or female < 65).
- Type 2 Diabetes mellitus or type 1 with microalbuminuria.
- Essential High Blood Pressure.
- Chronic Kidney Disease.
- Primary hyperlipidemia.
Key exclusion criteria (2 listed)
- Age < 40 or > 74 years old.
- Previous Cardiovascular Event.
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 |
|---|---|---|
| Simvastatin or AtorvastatinAlso: Simvastatin 10-40., Atorvastatin 20-40.Simvastatin 10-40 mg or Atorvastatin 20-40 mg will be prescribed according to LDL cholesterol reduction target. | Drug | 1 |
| EnalaprilAlso: ACE inhibitors., ACE + diureticEnalapril 10 mg/day will be prescribed as the initial treatment. Doses and adding drugs will be titrated accordingly | Drug | 1 |
| Aspirin or clopidogrelAlso: AntiplateletsAspirin 100 mg or clopidogrel 75 mg/ per day | Drug | 1 |
| RimonabantAlso: Rimonabant is allowed.In both arms, we will follow the standard clinical care in terms of treatments, as far as obesity and diabetes mellitus is concerned. Drugs will be prescribed as the standard clinical care | Drug | 1, 2 |
Primary outcome
Carotid Intima-Media Thickness progression/regression
Time frame: 2 years
1 secondary outcome
Cardio and cerebrovascular eventS
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2008.
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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.
Elvira Fernandez, MD,PhD principal investigator
Hospital Arnau de Vilanova
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 Simvastatin or Atorvastatin, Enalapril and Aspirin or clopidogrel in people with Atherosclerosis and Cardiovascular Diseases, run by Hospital Arnau de Vilanova 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 13 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: status not confirmed, as of the sponsor's last update on 14 Aug 2008. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Blai Coll, MD,PhD (+34 619633249, bcoll@arnau.scs.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carotid Intima-Media Thickness progression/regression (time frame: 2 years). 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 14 Aug 2008.