Condition category
Circulatory System
Date applied
07/11/2006
Date assigned
16/07/2007
Last edited
07/01/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The aim of this study is to compare up-to-date medical (conservative) treatment (BMT) including lifestyle modification with carotid artery stenting (CAS) and carotid endarterectomy (CEA) in addition to those conservative treatments in the treatment of individuals with asymptomatic atherosclerotic carotid artery stenoses.

Who can participate?
Patients with asymptomatic stenosis of the extracranial carotid artery. Asymptomatic means without stroke or stroke-like symptoms attributable to the target stenosis within the previous 180 days.

What does the study involve?
Patients are allocated to one of the two substudies based on the decision of the including physician and the patient's preference: either CEA (SPACE2a substudy) or CAS (SPACE2b substudy). Patients in the SPACE2a study will be randomly allocated to receive either CEA + BMT or BMT alone, while those in the SPACE2b study will be randomly allocated to receive either CAS + BMT or BMT alone. BMT is defined as the best medical treatment of hypertension, blood glucose and hyperlipidemia according to current guidelines.

What are the possible benefits and risks of participating?
The benefit from every treatment is the proposed reduction of future cerebrovascular and cardiovascular events. Each treatment arm carries specific risks. Risks from the conservative treatment are mainly due to possible side effects of the medication. The most important risk of both CAS and CEA is the risk of periprocedural stroke.

Where is the study run from?
University hospitals of Heidelberg, Kiel and Munich (technical university).

When is the study starting and how long is it expected to run for?
Recruitment of subjects started in October 2009. The overall duration of the trial is expected to be about 9 years.

Who is funding the study?
German Research Council (Deutsche Forschungsgemeinschaft [DFG]), Germany.

Who is the main contact?
Prof. Werner Hacke
Werner.Hacke@med.uni-heidelberg.de

Trial website

http://www.space-2.de/de/home/

Contact information

Type

Scientific

Primary contact

Prof Werner Hacke

ORCID ID

Contact details

Department of Neurology
University of Heidelberg
Im Neuenheimer Feld 400
Heidelberg
69120
Germany
+49 (0)6221-568211
Werner.Hacke@med.uni-heidelberg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Stent-protected angioplasty in asymptomatic carotid artery stenosis vs endarterectomy: a randomised, controlled, open, multi-centre study

Acronym

SPACE-2

Study hypothesis

Current hypothesis as of 19/12/2013:
Two separate superiority trials of interventions versus best medical treatment (BMT) are designed. The decision for one type of intervention is made (carotid endarterectomy [CEA] = SPACE2a or carotid artery stenting [CAS] = SPACE2b) prior to randomization. In both studies (SPACE2a and SPACE2b) the interventional treatment groups (CEA and CAS) will be compared with best medical treatment (BMT) separately. In addition, data from the CEA and CAS groups will be compared in an explorative manner.

Protocol can be found at: http://www.space-2.de/de/service/03/

Previous hypothesis:
1. Superiority of stent-protected angioplasty or carotid endarterectomy (CEA) as compared to best medical treatment with respect to the composite primary endpoint
2. Stent-protected angioplasty is not inferior to carotid endarterectomy with respect to the composite primary endpoint

On 11/02/2009 this record was updated to include an amended start date. The initial date at the time of registration was 01/07/2007.

On 19/12/2013 the following changes were made to the trial record:
1. The public title was changed from 'Stent-protected angioplasty in asymptomatic carotid artery stenosis: SPACE-2' to 'Stent-protected angioplasty in asymptomatic carotid artery stenosis vs endarterectomy: two two-arm clinical trials'
2. The scientific title was changed from 'Stent-protected angioplasty in asymptomatic carotid artery stenosis: a randomised, controlled, open, multi-centre study' to 'Stent-protected angioplasty in asymptomatic carotid artery stenosis vs endarterectomy: a randomised, controlled, open, multi-centre study'
3. The study design was changed from 'Randomised controlled open multi-centre study with three parallel groups' to 'Randomised controlled open multi-centre study with two two-arm clinical trials'
4. The target number of participants was changed from '3523' to '2 x 1636'

On 07/01/2014 the anticipated end date was changed from 01/07/2015 to 01/07/2020.

Ethics approval

Added 11/02/2009: Ethics Committee of the University of Heidelberg, 20/10/2008, ref: S-311/2008
Added 19/12/2013: Ethics Committee of the University of Heidelberg gave approval on change of study design (amendment 25.09.2012) on 04/04/2013

Study design

Randomised controlled open multi-centre study with two two-arm clinical trials

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Can be found at: http://www.space-2.de/downloads/SPACE-2%20Patienteninformation.pdf (German only)

Condition

Asymptomatic moderate to severe stenosis of the extracranial carotid artery

Intervention

Current interventions as of 19/12/2013:
Patients are allocated to one of the two substudies based on the decision of the including physician and the patient's preference: either CEA (SPACE2a substudy) or CAS (SPACE2b substudy). Patients in the SPACE2a study will be randomly allocated to receive either CEA + BMT or BMT alone, while those in the SPACE2b study will be randomly allocated to receive either CAS + BMT or BMT alone. BMT is defined as optimal medical treatment of hypertension, blood glucose and hyperlipidemia according to current guidelines.

Previous interventions:
1. BMT alone
2. Stent-protected angioplasty and BMT
3. Carotid endarterectomy and BMT

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Cumulative rate of events consisting of:
1. Any stroke within 30 days of treatment
2. Death from any cause within 30 days
3. Ipsilateral ischaemic stroke within five years

Secondary outcome measures

1. All single components of the primary endpoint clusters
2. Any stroke, vascular death or myocardial infarction within 30 days (five years)
3. Any ischaemic stroke within 30 days (five years)
4. Disabling stroke within 30 days (five years)
5. Technical failure of intervention
6. Rate of re-stenosis (NASCET more than or equal to 50%)
7. Rate of myocardial infarction (30 days)

Overall trial start date

01/03/2009

Overall trial end date

01/07/2020

Reason abandoned

Eligibility

Participant inclusion criteria

Sonographic identification of a more than or equal to 50% stenosis (North American Symptomatic Carotid Endarterectomy Trial [NASCET] criteria) of the extracranial carotid artery in a patient (both genders, age limit 85 years) without symptoms attributable to the target stenosis within the previous 180 days.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2 x 1636

Participant exclusion criteria

Non-atherosclerotic origin of carotid stenosis.

Recruitment start date

01/03/2009

Recruitment end date

01/07/2020

Locations

Countries of recruitment

Austria, Germany, Switzerland

Trial participating centre

Department of Neurology
Heidelberg
69120
Germany

Sponsor information

Organisation

German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)

Sponsor details

Kennedyallee 40
Bonn
53175
Germany
+49 (0)228-885-1
postmaster@dfg.de

Sponsor type

Research council

Website

http://www.dfg.de

Funders

Funder type

Research council

Funder name

German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19689759

Publication citations

  1. Protocol

    Reiff T, Stingele R, Eckstein HH, Fraedrich G, Jansen O, Mudra H, Mansmann U, Hacke W, Ringleb P, , Stent-protected angioplasty in asymptomatic carotid artery stenosis vs. endarterectomy: SPACE2 - a three-arm randomised-controlled clinical trial., Int J Stroke, 2009, 4, 4, 294-299, doi: 10.1111/j.1747-4949.2009.00290.x.

Additional files

Editorial Notes