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Diabetes Mellitus, Type 2Phase 4IDASCOP 1NCT03329261

Incidence of Major Cardiovascular Events in Diabetic Patients With ACS Undergoing Coronary Angioplasty and Treated With Clopidogrel 150 mg Versus 75 mg

A Phase 4 study testing Clopidogrel in people with Diabetes Mellitus, Type 2 and NSTEMI - Non-ST Segment Elevation MI, run by Laboratoires Teriak at 1 site in Tunisia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Clopidogrel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
167 participants
Where
1 siteTunisia
Study dates
7 Dec 2017to 20 Dec 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female aged between 18 to 75 years old.
  • Proven ACS requiring PTCA within 1 week of inclusion. The ACS should be without ST-segment elevation (presence of chest pain with ST-segment or T-wave changes without sustained ST segment elevation) with elevation of cardiac biomarkers of MI (positive troponins).
  • Coronary angiography showing at least one coronary lesion, whether mono, bi or multi-truncate
  • Type 2 diabetes confirmed for at least one year
  • Patient candidate for treatment with Clopidogrel
  • Informed consent of patients
Show all 27Show fewer
  • Non-Inclusion Criteria:
  • Non-consenting patient and/or participating in another clinical study
  • ACS with ST segment elevation (STEMI)
  • History of digestive or cerebral bleeding with antiplatelet agents or anticoagulants
  • Insulin-dependent diabetes mellitus (IDDM)
  • Diabetic requiring insulin
  • Patient in cardiogenic shock
  • Patient under treatment with anti-glycoprotein IIb/IIIa or stopped less than 72 hours prior to inclusion
  • Previously treated with clopidogrel or thrombolytics
  • Patients programmed for surgery in less than 6 months
  • Ischemic stroke less than 6 weeks old
  • History of haemorrhagic stroke (regardless of time)
  • Patients under or candidates for Vitamin K antagonist (VKA)
  • Patients under another antiplatelet agent (Ticlopidine, Prasugrel)
  • Patients with a contraindication to clopidogrel (hypersensitivity to the active substance or to any of the excipients, severe hepatic impairment, progressive hemorrhagic lesion such as peptic ulcer or intracranial hemorrhage)
  • Under omeprazole treatment, or considered during the study
  • Anemia (Hb <12g/dl)
  • Thrombocytopenia with less than 100000 cells/mm3
  • Serum creatinine greater than 200 μmol/l
  • Pregnancy and/or breast-feeding
  • Severe renal impairment

Who cannot join

  • Non-compliance with treatment (treatment compliance <80%)
  • AE/SAE requiring cessation of treatment
  • Planning a CABG
  • Occurrence of pregnancy during the study

Trial locations and contacts

1 site in 1 country.

Tunisia1 site

  • HMPIT

    Ben Arous

Other trials in Tunisia

About this study

Official title: Incidence Des évènements cArdiovasculaires majeurS Chez Les Patients COronariens diabétiques Subissant Une angioPlastie Coronaire et traités Par Clopidogrel à la Dose 150 mg Versus 75 mg

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.

Read the detailed description

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).

Being tested
Clopidogrel
Medical subject headings
Diabetes Mellitus, Type 2, Non-ST Elevated Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ClopidogrelDrug

    Also called COPIGREL®

    COPIGREL® - clopidogrel dosed at 75 mg per tablet

Study groups in NCT03329261
Study groupRoleWhat they receive
Arm 1 (single dose)Active comparatorWill 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.
Receives: Drug: Clopidogrel
Arm 2 (double dose)Active comparatorWill 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.
Receives: Drug: Clopidogrel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Cardiovascular Events (MACE)

    Incidence of major cardiovascular events including cardiac death, MI, cerebrovascular accident (CVA), revascularization (PTCA, GABG), stent thrombosis.

    Measured: 1 year after coronary intervention

Secondary outcomes (4)

  1. Bleeding Events

    All bleeding events (digestive, cerebral, other locations)

    Measured: At 1, 3, 6, 9 and 12 months from patient enrollment

  2. Heart Failure Readmission

    Incidence of heart failure hospital readmissions

    Measured: At 1, 3, 6, 9 and 12 months from patient enrollment

  3. Global Death

    Incidence of death of all causes (death of cardiovascular origin and death of non-cardiovascular origin)

    Measured: At 1, 3, 6, 9 and 12 months from patient enrollment

  4. Incidence of Adverse Events

    Incidence of Adverse Events (AE) including Serious Adverse Events (SAE)

    Measured: At 1, 3, 6, 9 and 12 months from patient enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2017
  2. Study start7 Dec 2017
  3. Primary completion24 Mar 2019
  4. Study completion20 Dec 2019

Resources

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
Model description
A comparative, interventional, multicenter, randomized, prospective, two-arm study with monotherapy in two different doses
Masking
None (open label)
Enrolment
167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03329261
Sponsor's protocol ID
TERIAK-001
Acronym
IDASCOP 1
Status last verified
Dec 2019
First submitted
14 Oct 2017
Last updated
23 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Clopidogrel in people with Diabetes Mellitus, Type 2 and NSTEMI - Non-ST Segment Elevation MI, run by Laboratoires Teriak 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 27 inclusion and 4 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 23 Dec 2019. 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.

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?

Major Cardiovascular Events (MACE) (time frame: 1 year after coronary intervention). 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 NCT03329261.

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 23 Dec 2019.

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