Basilar Artery International Cooperation Study (BASICS)
This study is currently recruiting participants.
Verified October 2012 by St. Antonius Hospital
Sponsor:
Erik van der Hoeven
Collaborator:
BASICS Study Group
Information provided by (Responsible Party):
Erik van der Hoeven, St. Antonius Hospital
ClinicalTrials.gov Identifier:
NCT01717755
First received: October 23, 2012
Last updated: October 26, 2012
Last verified: October 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Rationale: Recently our study group reported the results of the Basilar Artery International Cooperation Study (BASICS), a prospective registry of patients with an acute symptomatic basilar artery occlusion (BAO). Our observations in the BASICS registry underscore that we continue to lack a proven treatment modality for patients with an acute BAO and that current clinical practice varies widely. Furthermore, the often-held assumption that intra-arterial treatment (IAT) is superior to intravenous thrombolysis (IVT) in patients with an acute symptomatic BAO is challenged by our data. The BASICS registry was observational and has all the limitations of a non-randomised study. Interpretation of results is hampered by the lack of a standard treatment protocol for all patients who entered the study.
Objective: Evaluate the efficacy and safety of additional IAT after IVT in patients with basilar artery occlusion.
Study design: Randomised, multi-centre, open label, controlled phase III, treatment trial
Study population: Patients, aged 18 through 85 years, with CTA or MRA confirmed basilar occlusion treated with IVT.
Target number of participants: 750.
Intervention: Patients will be randomised between additional IAT followed by maximum supportive care versus maximum supportive care alone. IVT has to be initiated within 4.5 hours from estimated time of basilar artery occlusion and IAT within 6 hours.
Main study parameters/endpoints: Favourable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.
| Condition | Intervention | Phase |
|---|---|---|
|
Basilar Artery Thrombosis Basilar Artery Embolism Stroke of Basilar Artery Stroke Cerebrovascular Disorders |
Other: Intra-arterial treatment |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Basilar Artery International Cooperation Study |
Further study details as provided by St. Antonius Hospital:
Primary Outcome Measures:
- Favourable outcome [ Time Frame: day 90 ] [ Designated as safety issue: No ]Favourable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.
Secondary Outcome Measures:
- Excellent outcome [ Time Frame: day 90 ] [ Designated as safety issue: No ]Excellent outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-2.
- Modified Rankin Score [ Time Frame: day 90 ] [ Designated as safety issue: No ]Modified Rankin Score - not dichotomized.
- NIHSS [ Time Frame: pre IVT, pre randomization, 24h post treatment ] [ Designated as safety issue: No ]
National Institutes of Health Stroke Scale (NIHSS - acute assessment scale) at timepoints:
- directly pre intravenous thrombolysis
- directly pre randomization (post intravenous thrombolysis)
- at 24 hours +- 6 hours post treatment.
- EQ-5D [ Time Frame: day 90 and 12 months ] [ Designated as safety issue: No ]EQ-5D (quality of life) at day 90 and at 12 months.
Other Outcome Measures:
- Recanalization [ Time Frame: 24 hours ± 6 hours ] [ Designated as safety issue: No ]Recanalization at 24 hours ± 6 hours, by CT angiography.
- Volume of cerebral infarction [ Time Frame: 24 hours ± 6 hours ] [ Designated as safety issue: No ]Volume of cerebral infarction on NCCT and CTA source images.
- SICH [ Time Frame: 24 hours ± 6 hours. ] [ Designated as safety issue: Yes ]Symptomatic intracranial hemorrhage at 24 hours CT imaging ± 6 hours.
- Mortality [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]Mortality at 90 days.
| Estimated Enrollment: | 750 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | October 2017 |
| Estimated Primary Completion Date: | January 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: No additional intra-arterial treatment.
Intravenous thrombolysis followed by maximum supportive care.
|
|
|
Experimental: Additional intra-arterial treatment.
Intravenous thrombolysis followed by intra-arterial treatment and maximum supportive care.
|
Other: Intra-arterial treatment
The choice of the IA strategy will be made by the treating neurointerventionalist. IA treatment options available will be any of the following devices or thrombolytics, depending on local approval and experience; the Merci and Trevo thrombus-removal devices, Penumbra, Solitaire, infusion of rt-PA combined with an application of low-intensity ultrasound at the site of the occlusion via the EKOS Micro-Infusion Catheter, infusion of alteplase or urokinase via a standard micro-catheter. If IA thrombolysis is the chosen strategy, a maximum of 22 mg of IA rt-PA or 1.500.000 Units of Urokinase may be given. Stenting is allowed in the presence of a high-grade vertebral artery stenosis or occlusion hampering adequate endovascular access to the basilar artery and in case of a residual high-grade basilar artery stenosis.
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Symptoms and signs compatible with ischemia in the basilar artery territory and an NIHSS ≥ 10 at time of randomization.
- Basilar artery occlusion confirmed by CTA or MRA.
- Age18 through 85 years (i.e., candidates must have had their 18th birthday, but not had their 86th birthday).
- Initiation of IV rt-PA within 4.5 hours of estimated time of basilar artery occlusion. (Estimated time of basilar artery occlusion is defined as time of onset of acute symptoms leading to clinical diagnosis of basilar artery occlusion or if not known last time patient was seen normal prior to onset of these symptoms).
- Initiation of IA therapy should be feasible within 6 hours of estimated time of basilar artery occlusion.
Exclusion Criteria:
- Pre-existing dependency with mRankin ≥3.
- Females of childbearing potential who are known to be pregnant and/or lactating or who have positive pregnancy tests on admission.
- Patients who require hemodialysis or peritoneal dialysis.
- Other serious, advanced, or terminal illness.
- Any other condition that the investigator feels would pose a significant hazard to the patient if IA therapy is initiated.
- Current participation in another research drug treatment protocol (patient cannot start another experimental agent until after 90 days).
- Informed consent is not or cannot be obtained.
- Lesion consistent with hemorrhage of any degree.
- Significant cerebellar mass effect or acute hydrocephalus.
- Bilateral extended brainstem ischemia.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717755
Contacts
| Contact: Wouter Schonewille, MD | +31 6 41285149 | w.schonewille@antoniusziekenhuis.nl |
| Contact: Erik van der Hoeven, MD | +31 6 47490060 | e.van.der.hoeven@antoniusziekenhuis.nl |
Locations
| Italy | |
| University Hospital Modena | Recruiting |
| Modena, Italy, 41100 | |
| Principal Investigator: Andrea Zini, PhD | |
| Netherlands | |
| Rijnstate | Recruiting |
| Arnhem, Gelderland, Netherlands, 6800 TA | |
| Principal Investigator: Jeanette Hofmeijer, PhD | |
| Academic Hospital Maastricht | Recruiting |
| Maastricht, Limburg, Netherlands, 6229 HX | |
| Principal Investigator: Julie Staals, PhD | |
| St. Elisabeth Hospital | Recruiting |
| Tilburg, Noord Brabant, Netherlands, 5022 GC | |
| Principal Investigator: Paul de Kort, PhD | |
| St. Antonius Hospital | Recruiting |
| Nieuwegein, Utrecht, Netherlands, 3430 EM | |
| Principal Investigator: Wouter Schonewille, MD | |
| MCH Westeinde | Recruiting |
| The Hague, Zuid-Holland, Netherlands, 2512 VA | |
| Principal Investigator: Jelis Boiten, PhD | |
| Universitary Medical Center Utrecht | Recruiting |
| Utrecht, Netherlands, 3584 CX | |
| Principal Investigator: Jaap Kappelle, Prof. | |
| Switzerland | |
| University Hospital of Lausanne | Recruiting |
| Lausanne, Vaud, Switzerland, CH-1011 | |
| Principal Investigator: Patrik Michel, PhD | |
Sponsors and Collaborators
Erik van der Hoeven
BASICS Study Group
Investigators
| Principal Investigator: | W J Schonewille, MD | St. Antonius Hospital Nieuwegein |
More Information
Additional Information:
Publications:
| Responsible Party: | Erik van der Hoeven, E.J.R.J. van der Hoeven, MD, St. Antonius Hospital |
| ClinicalTrials.gov Identifier: | NCT01717755 History of Changes |
| Other Study ID Numbers: | NL33550.100.10, NHS2010B151, 2010-023507-95 |
| Study First Received: | October 23, 2012 |
| Last Updated: | October 26, 2012 |
| Health Authority: | Switzerland: Swissmedic Italy: The Italian Medicines Agency |
Keywords provided by St. Antonius Hospital:
|
basilar stroke mechanical thrombolysis intra-arterial |
Additional relevant MeSH terms:
|
Cerebrovascular Disorders Embolism Stroke Cerebral Infarction Thrombosis Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Embolism and Thrombosis Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 19, 2013