Incidence of Major Cardiovascular Events in Diabetic Patients With ACS Undergoing Coronary Angioplasty and Treated With Clopidogrel 150 mg Versus 75 mg (IDASCOP 1)
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.
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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-
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Ben Arous、チュニジア
- HMPIT
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion criteria:
- 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
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
Exclusion criteria:
- Non-compliance with treatment (treatment compliance <80%)
- AE/SAE requiring cessation of treatment
- Planning a CABG
- Occurrence of pregnancy during the study
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Arm 1 (single dose)
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.
|
COPIGREL® - clopidogrel dosed at 75 mg per tablet
他の名前：
|
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アクティブコンパレータ：Arm 2 (double dose)
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.
|
COPIGREL® - clopidogrel dosed at 75 mg per tablet
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Major Cardiovascular Events (MACE)
時間枠：1 year after coronary intervention
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Incidence of major cardiovascular events including cardiac death, MI, cerebrovascular accident (CVA), revascularization (PTCA, GABG), stent thrombosis.
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1 year after coronary intervention
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Bleeding Events
時間枠：At 1, 3, 6, 9 and 12 months from patient enrollment
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All bleeding events (digestive, cerebral, other locations)
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At 1, 3, 6, 9 and 12 months from patient enrollment
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Heart Failure Readmission
時間枠：At 1, 3, 6, 9 and 12 months from patient enrollment
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Incidence of heart failure hospital readmissions
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At 1, 3, 6, 9 and 12 months from patient enrollment
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Global Death
時間枠：At 1, 3, 6, 9 and 12 months from patient enrollment
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Incidence of death of all causes (death of cardiovascular origin and death of non-cardiovascular origin)
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At 1, 3, 6, 9 and 12 months from patient enrollment
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Incidence of Adverse Events
時間枠：At 1, 3, 6, 9 and 12 months from patient enrollment
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Incidence of Adverse Events (AE) including Serious Adverse Events (SAE)
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At 1, 3, 6, 9 and 12 months from patient enrollment
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- TERIAK-001
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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