dvt進(jìn)修醫(yī)師課件-資料下載頁(yè)
2025-02-21 13:31本頁(yè)面
【正文】 ? ’ written informed consent for participation after receiving detailed written and oral information prior to any study specific procedures 排除標(biāo)準(zhǔn) ? that contraindicate the use of antithrombotic therapy with the LMWH enoxaparin ? that may increase the risk of bleeding, including intracranial hemorrhage, such as: ? bleeding, within 30 days of randomization ? History of hemorrhagic stroke at any time in the past, ? Recent severe head trauma within 30 days of randomization ? Known intracranial neoplasm, cerebral metastases, arteriovenousmalformation, or aneurysm ? 3. Required drugs or procedures, such as: ? More than 2 days of prophylactic use of anticoagulants. Up to 2 doses of LMWH or up to 6 doses of unfractionated heparin prerandomization are allowed. ? Systemic treatment with more than 2 doses of strong inhibitors of cytochrome P450 3A4 (CYP 3A4) ? Indication for fibrinolysis or need for continued treatment withanticoagulant agents ? Treatment with or use of mechanical thromboprophylaxis (eg, pneumatic pression devices, foot pumps) for VTE prevention ? conditions or diseases, such as: ? Known allergy to rivaroxaban or any of its excipients ? Renal dysfunction ? Known significant liver disease ? Known human immunodeficiency virus (HIV) infection ? 〉 180/100mmHg ? Anemia ? History of ongoing drug or alcohol abuse ? Cardiogenic or septic shock ? would limit life expectancy to less than ? 6 months, ? : ? above knee lower extremity amputation ? Inability to take oral medication or otherwise unable or unwilling ? experimental drug or used an experimental medical ? device within 30 days ? Pregnancy or breastfeeding ? Previous participation in this study or any other study of rivaroxaban ? Employees of the investigator or study center, 干預(yù) /隨機(jī) ? Group1： Rivaroxaban 10 mg +placebo of enoxaparin ? Group2： 40 mg enoxaparin + placebo tablet of rivaroxaba ? Random： interactive voice response system (IVRS) Efficacy Variables——primary efficacy endpoint ? defined as a posite endpoint of the following ponents: ? Asymptomatic proximal lower extremity DVT detected by mandatory bilateral lower extremity venous ultrasonography at Day 35 177。 4 days ? Symptomatic lower extremity DVT (proximal or distal) up to Day 35 + 4 days ? Symptomatic non fatal PE up to Day 35 + 4 days ? VTE related death up to Day 35 + 4 days Efficacy Variables—— major secondary endpoint ? the primary efficacy endpoint (as above), with the addition of allcause mortality, up to Day 35 + 4 days. ? Further secondary endpoints are given by: Safety Variables ——Major bleeding event ? Major bleeding is defined as clinically overt bleeding that is associated with: ? A fall in hemoglobin of 2 g/dL or more, or ? A transfusion of 2 or more units of packed red blood cells or whole blood, or ? A critical site: intracranial, intraspinal, intraocular, pericardial, intraarticular, ? intramuscular with partment syndrome, retroperitoneal, or ? Death ? Nonmajor clinically relevant bleeding event ? Minimal bleeding event ? Other safety endpoints 結(jié)局評(píng)價(jià) ? Bilateral lower extremity venous ultrasonography is mandatory for all patients. The ultrasonogram should be performed after the last dose of study medication, within 24 hours of its administration. ? In case of premature discontinuation of study treatment, all assessments as described for visit Day 35 177。 4 days must be performed at the time of discontinuation, including bilateral lower extremity venous ultrasonography. All assessments should also be repeated on Day 35 177。 4 days. ? If the studies confirm the diagnosis of DVT or PE, no further study medication will be administered. 樣本量 ? 3% for the parator group, ? relative risk reduction =45% ? sample size =2763 subjects per group ? nonevaluable ultrasonography, ? maximum total sample size of randomized subjects = 8000. 亞組研究 急性腦梗死應(yīng)用伊諾肝素或口服凝血因子 X抑制劑抗凝治療出血轉(zhuǎn)化的發(fā)生率：前瞻性隊(duì)列研究 ? 納入、排除標(biāo)準(zhǔn)：同 RCT（ MAGELLAN） ? 結(jié)局： HT（ HI/PH） ? 評(píng)價(jià)時(shí)間（ ？ ）：在發(fā)病 5天 177。 2天或癥狀?lèi)夯?？ ）時(shí)立即 ? 評(píng)價(jià)方法： CT ? HT危險(xiǎn)因素 （ ？ ） ? 樣本量： 500（ ？）
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