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Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2) I期, II期 82 随机化 双盲 安慰剂对照
The study will involve a dose escalation stage and a co...
显示更多Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2
- iSPASM-2
- Pro00119469
- UG3NS138219 (美国 NIH 拨款/合同)
II期
Delayed Cerebral Ischemia
Tirofiban
Brain Aneurysm Rupture
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Tirofiban Continuous IV infusion of tirofiban for 1, 3, 5, or 7 days post-endovascular coiling. | Tirofiban IV infusion at 0.10 microgram/kilogram/minute (mcg/kg/min) for 1 day, 3 days, 5 days, or 7 days according to the dose escalation procedure. |
安慰剂对照Placebo Continuous IV infusion of saline placebo for 1, 3, 5, or 7 days post-endovascular coiling. | 安慰剂 IV infusion at the same infusion duration as the study drug; same adjustments |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Tirofiban dosage-limiting toxicity (DLT) | Presence of any of the following: any intracranial hemorrhage, major extracranial hemorrhage (defined as clinically overt bleeding leading to death; OR clinically overt bleeding causing a reduction in hemoglobin of ≥2g/dl; OR clinically overt bleeding necessitating transfusion of ≥2 units of packed red cells or whole blood; OR clinically overt bleeding in a critical area or organ other than the intracranial compartment (including intraspinal, intraocular, pericardial, intra-articular, retroperitoneal, intramuscular \[with compartment syndrome\])), thrombocytopenia, or serious adverse event (SAE) due to tirofiban. | Within 14 days post-randomization |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Pharmacokinetic parameters - total clearance (Cltot) | Up to 7 hours after drug discontinuation | |
Pharmacokinetic parameters - Volume of distribution (Vd) | Up to 7 hours after drug discontinuation | |
Pharmacokinetic parameters - Maximum (peak) plasma concentration (Cmax) | Highest concentration of tirofiban in the blood after a dose is administered | Up to 7 hours after drug discontinuation |
Pharmacokinetic parameters - Minimum (trough) plasma concentration (Cmin) | Lowest observed concentration of tirofiban in the blood after a dose is administered | Up to 7 hours after drug discontinuation |
Pharmacokinetic parameters - Average Plasma Concentration (Cavg) | Average tirofiban concentration in the blood at steady state | Up to 7 hours after drug discontinuation |
Pharmacokinetic parameters - Area Under the Concentration (AUC)Time Curve | Area under the curve from time 0 extrapolated to infinite time | Up to 7 hours after drug discontinuation |
Pharmacodynamic parameters - adenosine diphosphate (ADP) | The percent inhibition of ADP-induced platelet aggregation | Baseline, 2, 6, and every 24 hours and at drug cessation |
Inclusion:
- Age 18-85
- Baseline Modified Rankin Scale (mRS) 0-3 (pre-SAH)
- SAH attributed to ruptured cerebral aneurysm
- Admission Computed Tomography (CT) scan shows Modified Fisher grade 1-4 due to aSAH primarily in the supratentorial space
- World Federation of Neurosurgical Societies (WFNS) scale grade ≤4 at randomization
- Onset of symptoms of aSAH (ictus) occurred <72 hours prior to presentation
- If External Ventricular Drain (EVD) placed, placement is ≥12 hours prior to enrollment
- All aneurysm(s) suspected to be responsible for the hemorrhage must be secured via Endovascular Coil Embolization with a post-embolization Raymond-Roy Score of 1 (Complete) or 2 (Residual Neck) prior to enrollment
- Participant can be randomized within 48 hours of aneurysm treatment
- Participant or participant's legally-authorized representative (LAR) has provided documented informed consent
Exclusion:
Angio-negative SAH, defined as a SAH with a digital subtraction angiogram that does not show an intracranial aneurysm
Surgical clipping prior of the ruptured aneurysm or any non-ruptured aneurysm on the same admission to enrollment
Remaining untreated aneurysm(s) that could reasonably be considered a possible alternate cause of the aSAH based on the observed bleeding pattern
Uncontrollable hypertension (>180 systolic and/or >110 diastolic) that is not correctable prior to enrollment
Active internal bleeding, or history of bleeding diathesis, major surgical procedure, or severe physical trauma within the previous month (30 days)
A medical diagnosis that requires continuous use of aspirin, clopidogrel, ticagrelor, or tirofiban during the study drug infusion
New parenchymal hemorrhage or new infarction larger than 15 cubic centimeters (cc) in volume by CT
Thrombolytic therapy within 24 hours prior to enrollment (alteplase, tenecteplase, or urokinase)
Previous intracranial hemorrhage, intracranial neoplasm, subarachnoid hemorrhage, or arterial-venous malformation
Thrombocytopenia (platelet count <100,000/microliter (µL) assuming clumping is ruled out
Allergy or intolerance to tirofiban
Pregnant or lactating
Chronic kidney disease with creatinine clearance (CrCl ≤ 30 milliliters per minute \[ml/min\]) or acute kidney injury (AKI) at study screening. AKI is defined as:
i) Increase in serum creatinine by 0.3 milligrams per deciliter (mg/dL) or more (26.5 micromoles per liter \[μmol/L\] or more) within 48 hour period; OR ii) Increase in serum creatinine to 1.5 times or more than the baseline of the prior 7 day period; OR iii) Urine volume less than 0.5 ml/kg/hour for at least 6 hours
Dr David Hasan, M.D.- National Institutes of Health (NIH)
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