Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Thrombolysis or Anticoagulation for Cerebral Venous Thrombosis (TOACT)
Brief Summary: Background: Endovascular thrombolysis, with or without mechanical clot removal (ET), may be beneficial for a subgroup of patients with cerebral venous sinus thrombosis (CVT), who have a poor prognosis despite treatment with heparin. Published experience with ET is promising, but only based on case series and not on controlled trials.

Objective: The main objective of the TO-ACT trial is to determine if ET improves the functional outcome of patients with a severe form of CVT

Study design: The TO-ACT trial will be designed as a multi-centre, prospective, randomized, open-label, blinded endpoint (PROBE) trial.

Study population: Patients are eligible if they have a radiologically proven CVT, a high probability of poor outcome (defined by presence of one or more of the following risk factors: mental status disorder, coma, intracranial hemorrhagic lesion or thrombosis of the deep cerebral venous system) and the responsible physician is uncertain if ET or standard anti-coagulant treatment is better.

Intervention: Patients will be randomized to receive either ET or standard therapy (therapeutic doses of heparin). ET consists of local application of alteplase or urokinase within the thrombosed sinuses, and/or mechanical thrombectomy. Glasgow coma score, NIH stroke scale and relevant laboratory parameters will be assessed at baseline.

Endpoints: The primary endpoint is the modified Rankin scale (mRS) at 12 months. The most important secondary outcomes are the mRS, mortality and recanalization rate at 6 months. Major intra- and extracranial hemorrhagic complications within one week following the intervention are the principal safety outcome. Results will be analyzed according to the "intention-to-treat" principle. Assessment of study endpoints will be carried out according to standardized questionnaires by a blinded neurologist or research nurse who is not involved in the treatment of the patient.

Study size: To detect a 50% relative reduction in mRS≥2 (from 40 to 20%), 164 patients (82 in each treatment arm) have to be included (two-sided alpha, 80% power).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Included patients may benefit directly from ET. Complications of ET, most notably intracranial hemorrhages, constitute the most important risk of the study.


Options:
A: Arm Label: Low dose Argatroban + rt-PA (alteplase); Type: EXPERIMENTAL; Interventions: Drug: Low Dose Argatroban, Drug: rt-PA (alteplase) | Arm Label: High dose Argatroban + rt-PA (alteplase); Type: EXPERIMENTAL; Interventions: Drug: High Dose Argatroban, Drug: rt-PA (alteplase) | Arm Label: rt-PA (alteplase); Type: ACTIVE_COMPARATOR; Interventions: Drug: rt-PA (alteplase) | Intervention Type: DRUG; Name: Low Dose Argatroban; Assigned to Arm(s): Low dose Argatroban + rt-PA (alteplase) | Intervention Type: DRUG; Name: High Dose Argatroban; Assigned to Arm(s): High dose Argatroban + rt-PA (alteplase) | Intervention Type: DRUG; Name: rt-PA (alteplase); Assigned to Arm(s): High dose Argatroban + rt-PA (alteplase), Low dose Argatroban + rt-PA (alteplase), rt-PA (alteplase)
B: Arm Label: Endovascular thrombolysis; Type: EXPERIMENTAL; Interventions: Drug: Endovascular thrombolysis | Arm Label: Standard treatment; Type: ACTIVE_COMPARATOR; Interventions: Drug: Heparin | Intervention Type: DRUG; Name: Endovascular thrombolysis; Assigned to Arm(s): Endovascular thrombolysis | Intervention Type: DRUG; Name: Heparin; Assigned to Arm(s): Standard treatment
C: Arm Label: Early start of NOAC; Type: ACTIVE_COMPARATOR; Interventions: Other: Early start of NOAC | Arm Label: Late start of NOAC; Type: ACTIVE_COMPARATOR; Interventions: Other: Late start of NOAC | Intervention Type: OTHER; Name: Early start of NOAC; Assigned to Arm(s): Early start of NOAC | Intervention Type: OTHER; Name: Late start of NOAC; Assigned to Arm(s): Late start of NOAC
D: Arm Label: Heparin; Type: EXPERIMENTAL; Interventions: Drug: Heparin, Drug: Placebo | Arm Label: Nadroparin; Type: EXPERIMENTAL; Interventions: Drug: Nadroparin, Drug: Placebo | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Heparin, Drug: Nadroparin | Intervention Type: DRUG; Name: Heparin; Assigned to Arm(s): Heparin, Placebo | Intervention Type: DRUG; Name: Nadroparin; Assigned to Arm(s): Nadroparin, Placebo | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Heparin, Nadroparin

Answer: B