A Phase 4 interventional study of Clopidogrel in Diabetes Mellitus, Type 2, NSTEMI - Non-ST Segment Elevation MI and Coronary Angioplasty, sponsored by Laboratoires Teriak. Completed at 1 site in Tunisia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-12-23.
Sponsored by Laboratoires Teriak · Phase 4, Interventional, and Treatment
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Among 19 studies in Diabetes Mellitus, Type 2 with a site in Tunisia — 2 open to participants now, 2 under way, 1 of them phase 3. Diabetes Mellitus, Type 2 · Tunisia.
Among the 19 studies in Diabetes Mellitus, Type 2 with a site in Tunisia, this one is the 11th largest by enrollment of the 14 interventional ones that give a count, is the only one that started in 2017, is one of 5 in phase 4, and was the 13th registered.
10,378 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,410 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →2 of the 19 studies in Diabetes Mellitus, Type 2 with a site in Tunisia are open now. Recruiting first, the newest first:
University of Monastir · Sites in Tunisia
Ages 18–100
University Tunis El Manar · Sites in Tunisia
Ages 18–65
A study can be open while its sites in Tunisia have not opened yet or have stopped. Only those recruiting at a site in Tunisia →
Of the 882 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
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19 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 2 · Phase 3 8 · Phase 4 5
First in 2008; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 167 is above the median of 80 across 8,356 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 519 across the 14 interventional studies, 10,145 across the 5 observational. Of the 16 that completed or were terminated, 7 (44%) have results posted.
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13 of 19 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Laboratoires Teriak as lead sponsor.
Laboratoires Teriak has 1 study filed under Diabetes Mellitus, Type 2 — fewer than ten, so there is no comparison to draw.
1 of the studies in Diabetes Mellitus, Type 2 with a site in Tunisia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07467967University Tunis El ManarImpact of Date Consumption on Metabolic Control and Oxidative Stress in Patients With Type 2 Diabetes | 2027-02-20 |
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Among the 19 studies in Diabetes Mellitus, Type 2 with a site in Tunisia, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Acute Coronary Syndrome (ACS) is triggered by the rupture of an atherosclerotic plaque that results in a platelet aggregation reaction in the coronary artery. The administration of antiplatelet agents starting from the acute phase of the disease has helped reduce the risk of ischemic relapse both during initial and long-term hospitalization.
Management of clopidogrel following an ischemic event has been the subject of several treatment regimens ranging from a single continuous dose to a sequential double dose of between 7 and 30 days. The CURRENT-OASIS 7 therapeutic trial showed a benefit of clopidogrel double dose in reducing the risk of myocardial intervention (MI) and the composite outcome: cardiovascular mortality, MI, or stroke (CVA/TIA) at 30 days. However, the study protocol was interested in all ACSs, regardless of the Type 2 Diabetes Mellitus (T2DM) status in selected patients. Also, doubling of clopidogrel dose was maintained over 7 days after angioplasty. The literature describes an increased cardiovascular risk in type II diabetics in secondary prevention. No previous study has evaluated the effect of clopidogrel double dose given for 1 month on the reduction of this risk in the long-term in diabetic patients.
Thus, the objective of this study is to evaluate the efficacy and safety of clopidogrel double dose, given for 1 month in ACS in the diabetic patient.
The study is an open label, multicentric clinical trial. Collected data are managed by the DACIMA Clinical Suite®, the electronic data capture platform which complies with the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation).
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Non-Inclusion Criteria:
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Will receive a clopidogrel loading dose of 600 mg PO, then a daily dose of clopidogrel 75 mg PO until the angioplasty is performed. After coronary intervention, a daily dose of clopidogrel 150 mg PO for 7 days will be given, followed by a daily single dose of clopidogrel (75 mg PO) for 21 days. Maintenance therapy will be clopidogrel daily dose of 75 mg PO thereafter, until the end of the study.
Drug: Clopidogrel
Will receive a clopidogrel loading dose of 600 mg PO, then a daily dose of clopidogrel 75 mg PO until the angioplasty is performed. After coronary intervention, a daily dose of clopidogrel 150 mg PO for 7 days will be given, followed by a daily double dose of clopidogrel (150 mg PO) for 21 days. Maintenance therapy will be clopidogrel daily dose of 75 mg PO thereafter, until the end of the study.
Drug: Clopidogrel
COPIGREL® - clopidogrel dosed at 75 mg per tablet
Also known as: COPIGREL®
Major Cardiovascular Events (MACE)
Incidence of major cardiovascular events including cardiac death, MI, cerebrovascular accident (CVA), revascularization (PTCA, GABG), stent thrombosis.
Time frame: 1 year after coronary intervention
Bleeding Events
All bleeding events (digestive, cerebral, other locations)
Time frame: At 1, 3, 6, 9 and 12 months from patient enrollment
Heart Failure Readmission
Incidence of heart failure hospital readmissions
Time frame: At 1, 3, 6, 9 and 12 months from patient enrollment
Global Death
Incidence of death of all causes (death of cardiovascular origin and death of non-cardiovascular origin)
Time frame: At 1, 3, 6, 9 and 12 months from patient enrollment
Incidence of Adverse Events
Incidence of Adverse Events (AE) including Serious Adverse Events (SAE)
Time frame: At 1, 3, 6, 9 and 12 months from patient enrollment
Ran from Dec 2017 to primary completion in Mar 2019, 15 months.
Of 132 industry-sponsored phase 4 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 28. This study's 15 months is below that.
Counting every sponsor, half of 452 studies reached it within 24 months; a quarter within 13 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Clopidogrel