NCT03594045终止2 期
A Phase II Study to Evaluate the Efficacy and Safety of Apixaban in the Treatment of Heparin Induced Thrombocytopenia (HIT)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- Cumulative Incidence of New Symptomatic Thromboembolic Complications (TEC) Within 30 Days of the Initiation of Apixaban
研究概览
简要总结
This research study is studying a drug as a possible treatment for heparin induced thrombocytopenia (HIT) or Heparin-induced Thrombocytopenia and Thrombosis (HITT).
The drug involved in this study is apixaban.
详细描述
This research study is a Phase II clinical trial.
The FDA (the U.S. Food and Drug Administration) has not approved apixaban as a treatment option for this specific disease but it has been approved for other uses.
HIT and HITT are common and severe complications of heparin therapy. Once patients are diagnosed with either one of these, they are typically switched to a non-heparin anticoagulant (a type of drug that thins your blood). As of now the only drug that is FDA approved for HIT or HITT is argatroban, which is administered continuously through an IV over multiple days and is extremely costly.
In this research study, the investigators are researching the activity and tolerability of apixaban in participants with HIT or HITT. The investigators believe that apixaban will work just as well as argatroban and will be more convenient for this population. The oral route of apixaban allows for the potential outpatient treatment of HIT or HITT which is both convenient and less expensive than treatment with argatroban.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patients at MGH and participating Dana Farber/Harvard Cancer Center (DF/HCC) sites.
- •Patient must have a diagnosis of HIT or high clinical suspicion of HIT, with a 4 T score of ≥ 5 as calculated by the following criteria:
- •Thrombocytopenia
- •Platelet count fall >50 percent and nadir ≥20,000/microL - 2 points
- •Platelet count fall 30 to 50 percent or nadir 10 to 19,000/microL - 1 points
- •Platelet count fall <30 percent or nadir <10,000/microL - 0 points
- •Timing of platelet count fall
- •Clear onset between days 5 and 10 or platelet count fall at ≤1 day if prior heparin exposure within the last 30 days - 2 points
- •Consistent with fall at 5 to 10 days but unclear (eg, missing platelet counts), onset after day 10, or fall ≤1 day with prior heparin exposure within 30 to 100 days - 1 point
- •Platelet count fall at <4 days without recent exposure - 0 points
- •Thrombosis or other sequelae
- •Confirmed new thrombosis, skin necrosis, or acute systemic reaction after intravenous unfractionated heparin bolus - 2 points
- •Progressive or recurrent thrombosis, non-necrotizing (erythematous) skin lesions, or suspected thrombosis that has not been proven - 1 point
- •None - 0 points
- •Other causes for thrombocytopenia
- •None apparent - 2 points
- •Possible - 1 point
- •Definite - 0 points
- •Prior to or immediately subsequent to enrollment, the patient must have the diagnosis confirmed by Heparin-PF4 EIA or other accepted confirmatory test to remain on study.
- •Patients can be treated with argatroban, bivalirudin or fondaparinux for up to 72 hours prior to enrollment.
- •Age 18 years or older.
- •ECOG performance status ≤2 (Karnofsky ≥60%)
- •Participants must have organ and marrow function as defined below:
- •absolute neutrophil count ≥1,500/mcL
- •AST(SGOT) and ALT(SGPT) ≤2.5 × institutional upper limit of normal
- •creatinine clearance ≥25 mL/min as was used in the AMPLIFY trial16
- •The effects of apixaban on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study entry, for the duration of the study participation, and 4 months after completion of apixaban administration.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patient requires anticoagulation for a mechanical heart valve.
- •Patient requires:
- •anticoagulation for another indication for long-term anticoagulation therapy,
- •dual antiplatelet therapy,
- •treatment with aspirin at a dose of more than 162 mg daily
- •Patient has signs of active or ongoing clinically significant hemorrhage.
- •Patient has hereditary or acquired coagulopathy or bleeding disorder.
- •Patient has a contraindication to apixaban.
- •Participants receiving any medications or substances that are inhibitors or inducers of cytochrome P-450 3A4 or p-glycoprotein are ineligible. Because this list of these agents are constantly changing, it is important to regularly consult a frequently-updated list. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.
- •Patient has severe renal insufficiency (CrCl <25 ml/min-as used in the AMPLIFY trial)
- •Patient has hepatic disease (including Child-Pugh B and C) associated with coagulopathy or clinically relevant bleeding risk.
- •Recent (previous seven days), or complicated lumbar puncture or epidural catheter placement or removal.
- •Patient has high potential need to undergo a surgical or major invasive procedure in the near future.
- •Patient has a history of uncorrected cerebral aneurysm, intracranial tumor or hemorrhagic cerebrovascular accident.
- •Patient refuses to receive transfused blood products should this intervention become clinically indicated.
- •Patient is taking or has been taking an investigational drug within the previous 30 days prior to enrollment.
- •In the judgment of the investigator, any disease or circumstance that would interfere with the objectives of the study.
- •Participants with known brain metastases.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to apixaban.
- •Uncontrolled intercurrent illness.
- •Pregnant women are excluded; breastfeeding should be discontinued if the mother is treated with apixaban.
- •Prior treatment with a non-heparin anticoagulant while awaiting study enrollment is not an exclusion.
研究组 & 干预措施
Apixaban for HITT
Experimental
Patients with Heparin Induced Thrombocytopenia with Thrombosis (HITT) will receive Apixaban, at an initial dose of 10 mg orally twice a day for 7 days followed by 5 mg twice a day for a total of 3 months.
干预措施: Apixaban (Drug)
Apixaban for HIT
Experimental
Patients with Heparin Induced Thrombocytopenia (HIT) will receive Apixaban, at an initial dose of 10 mg orally twice a day for 7 days followed by 5 mg twice a day for a total of 30 days.
干预措施: Apixaban (Drug)
结局指标
主要结局
Cumulative Incidence of New Symptomatic Thromboembolic Complications (TEC) Within 30 Days of the Initiation of Apixaban
时间窗: 30 days
New TEC
次要结局
- Cumulative Incidence of Limb Amputation(From the start of treatment until 30 days after the end of treatment, up to 60 days total for participants with HIT and up to 120 days total for participants with HITT)
- Time to Platelet Recovery(From the start of treatment until time of platelet recovery, up to 60 days total for participants with HIT and up to 120 days total for participants with HITT)
- Composite Cumulative Incidence of All-cause Mortality, Limb Amputation and New TEC(From the start of treatment until 30 days after the end of treatment, up to 60 days total for participants with HIT and up to 120 days total for participants with HITT)
- Cumulative Incidence of Major Bleeding(From the start of treatment until 30 days after the end of treatment, up to 60 days total for participants with HIT and up to 120 days total for participants with HITT)
- Cumulative Incidence of All Cause Mortality(From the start of treatment until the time of death or until 30 days after the end of treatment, up to 60 days total for participants with HIT and up to 120 days total for participants with HITT)
- Cumulative Incidence of New Thromboembolic Complications (TEC)(From the start of treatment until 30 days after the end of treatment, up to 60 days total for participants with HIT and up to 120 days total for participants with HITT)
- Composite Cumulative Incidence of New TEC and Major Bleeding(From the start of treatment until 30 days after the end of treatment, up to 60 days total for participants with HIT and up to 120 days total for participants with HITT)
研究者
Rachel P. Rosovsky, MD
Principal Investigator
Massachusetts General Hospital
研究点 (3)
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