Secondary PreventionNATURE STOP-CHNCT07034274
National Tunisian Clinical Registry on CardioVascular Secondary Prevention Clinical
An observational study of Secondary Prevention and CHD, run by Dacima Consulting at 1 site in Tunisia.
Trial summary
A non-interventional, national longitudinal multicenter study of CV secondary prevention in Tunisia Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Secondary Prevention, CHD, CV Risk
- How many people
- 7,284 participants
- Where
- 1 siteTunisia
- Study dates
- 9 Jun 2025to 31 Jul 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
Study population: All patients who had a coronary event in 2024
Who may be able to join
- Age > 18 years and < 80 years
- Patients who have been hospitalized for at least one acute coronary event with coronary revascularization, either percutaneous or surgical by coronary artery bypass grafting, or who have confirmed coronary artery disease requiring optimal medical treatment for more than 6 months
- Coronary event happening in 2024
- Informed, read and signed consent
Who cannot join
- Familial hypercholesterolemia
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Tunisian Society of Cardiology and Cardiovascular Surgery
Tunis, 1003
About this study
A non-interventional, national longitudinal multicenter study of CV secondary prevention in Tunisia
Read the detailed description
The NATURE-STOP-CHD study is carried out in Tunisia at cardiology consultations in hospitals and in the liberal sector. The study is a longitudinal non-interventional registry of patient undergoing secondary CV prevention. The data collected are managed by the DACIMA Clinical Suite® platform, which complies with international standards: FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPPA (Health Insurance Portability and Accountability Act), ICH (International Conference on Harmonisation), MedDRA (Medical Dictionary for Regulatory Activities). The DACIMA Clinical Suite® platform allows to track the data entered, check for inconsistencies and missing data, and schedule monitoring visits. A Steering Committee is set up to monitor patient inclusions, verify data sources, perform audit trails and prepare the statistical analysis plan for the study.
- Conditions
- Secondary Prevention, CHD, CV Risk
- Keywords
- Secondary Prevention, STCCCV, CHD, CV Risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Coronary Event | Patient with any coronary event |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance
Number of subjects with sufficient adherence to their cardiovascular medication
Measured: From enrollment to the end of the follow-up (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start9 Jun 2025
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary PreventionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,284 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Dacima Consulting
- Sponsor type
- University, hospital or other
- Collaborators
- Tunisian Society of Cardiology and Cardiovascular Surgery
- Responsible party
- Sponsor
- Investigators
- Youssef Ben Ameur, MD, Study chair, Tunisian Society of Cardiology and Cardiovascular SurgerySalma Charfeddine, MD, Study chair, Tunisian Society of Cardiology and Cardiovascular SurgeryIhsen Zairi, MD, Study chair, Tunisian Society of Cardiology and Cardiovascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034274
- Sponsor's protocol ID
- DAC-017-NATURE STOP-CHD
- Acronym
- NATURE STOP-CH
- Status last verified
- May 2026
- First submitted
- 15 Jun 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Needs prior authorization from the National Authority for the Protection of Personal Data, for any health data transfer outside the Tunisian territory
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Tunisian Clinical Registry on CardioVascular Secondary Prevention Clinical
- ClinicalTrials.gov ID
- NCT07034274
- Acronym / sponsor ID
- NATURE STOP-CH / DAC-017-NATURE STOP-CHD
- Conditions
- Secondary Prevention, CHD, CV Risk
- Keywords
- Secondary Prevention, STCCCV, CHD, CV Risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,284 participants (actual)
- Lead sponsor
- Dacima ConsultingUniversity, hospital or other
- Collaborators
- Tunisian Society of Cardiology and Cardiovascular Surgery
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 24 Jun 2025 (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.
A non-interventional, national longitudinal multicenter study of CV secondary prevention in Tunisia
Detailed description
The NATURE-STOP-CHD study is carried out in Tunisia at cardiology consultations in hospitals and in the liberal sector. The study is a longitudinal non-interventional registry of patient undergoing secondary CV prevention. The data collected are managed by the DACIMA Clinical Suite® platform, which complies with international standards: FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPPA (Health Insurance Portability and Accountability Act), ICH (International Conference on Harmonisation), MedDRA (Medical Dictionary for Regulatory Activities). The DACIMA Clinical Suite® platform allows to track the data entered, check for inconsistencies and missing data, and schedule monitoring visits. A Steering Committee is set up to monitor patient inclusions, verify data sources, perform audit trails and prepare the statistical analysis plan for the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary Event | – | –Patient with any coronary event |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who had a coronary event in 2024
Key inclusion criteria (4 listed)
- Age > 18 years and < 80 years
- Patients who have been hospitalized for at least one acute coronary event with coronary revascularization, either percutaneous or surgical by coronary artery bypass grafting, or who have confirmed coronary artery disease requiring optimal medical treatment for more than 6 months
- Coronary event happening in 2024
- Informed, read and signed consent
Key exclusion criteria (1 listed)
- Familial hypercholesterolemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compliance
Time frame: From enrollment to the end of the follow-up (12 months)
Number of subjects with sufficient adherence to their cardiovascular medication
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 11 May 2026.
- Website of the Tunisian Society of Cardiology and Cardiovascular SyrgeryLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Needs prior authorization from the National Authority for the Protection of Personal Data, for any health data transfer outside the Tunisian territory
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RecruitingPhase 3
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RecruitingPhase 2/3
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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.
Youssef Ben Ameur, MD study chair
Tunisian Society of Cardiology and Cardiovascular Surgery
Salma Charfeddine, MD study chair
Tunisian Society of Cardiology and Cardiovascular Surgery
Ihsen Zairi, MD study chair
Tunisian Society of Cardiology and Cardiovascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Secondary Prevention and CHD, run by Dacima Consulting at 1 site in Tunisia.
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 4 inclusion and 1 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 11 May 2026. 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 Tunisia. 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.
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?
Compliance (time frame: From enrollment to the end of the follow-up (12 months)). 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 11 May 2026.