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PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years (CLOSE-2)

Primary Purpose

Cryptogenic Ischemic Stroke, Patent Foramen Ovale

Status

Not yet recruiting

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Transcatheter PFO closure

Oral Anticoagulant, Direct-Acting

Antiplatelet therapy

About this trial

This is an interventional prevention trial for Cryptogenic Ischemic Stroke focused on measuring Ischemic stroke, Cryptogenic stroke, Patent foramen ovale, Atrial septal aneurysm, Transcatheter PFO closure, Oral anticoagulants, Antiplatelet therapy, Randomized clinical tria

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Man or woman aged 60 to 80 years.
Recent (≤ 6 months) ischemic stroke confirmed by cerebral imaging regardless of symptom duration.
Absence of a more probable cause of stroke than PFO after a standardized etiological work-up (see addenda). Presence of a PFO with at least 1 of the 2 following characteristics:
- PFO with large shunt (> 20 microbubbles appearing inthe left atrium within 3 cardiac cycles after opacification of the right atrium) detected spontaneously or during provocative maneuvers,
- PFO with ASA on transesophageal echocardiography (TOE): base of aneurysm >= 15mm and excursion >10 mm.
Affiliation to a French Health Insurance system. Informed consent.

Exclusion Criteria:

Life expectancy < 4 years.
Contraindication to both experimental treatments (PFO closure, oral anticoagulant therapy) or to the reference treatment (antiplatelet therapy) (see paragraph 19.5). Indication to long-term anticoagulant therapy.
mRS >= 3.
Presence of other medical conditions that would lead to inability to complete the study or interfere with the assessment of outcomes.
Previous surgical or transcatheter treatment of PFO or ASA. Expected impossible follow-up or poor compliance.
Patient unable to understand the informed consent form. Patient under tutorship, curatorship, or legal protection.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Antiplatelet therapy

Oral anticoagulants, Direct-Acting

PFO closure

Arm Description

Aspirin OR clopidogrel

Apixaban (5mg twice a day) OR Dabigatran (150 mg twice a day) OR Rivaroxaban (20 mg once a day)

PFO closure followed by dual antiplatelet therapy (aspirin 75 mg/d + clopidogrel 75 mg/d) for 3 months, then by single antiplatelet therapy by aspirin or clopidogrel

Outcomes

Primary Outcome Measures

Time to recurrent stroke (ischemic or hemorrhagic fatal or non-fatal)

Stroke: sudden onset of focal neurological symptoms related to a disturbance of the cerebral circulation. Ischemic stroke : at least one of the following criteria: Sudden onset of focal neurological symptoms with the presence of cerebral infarction in the appropriate territory on brain imaging (CT or MRI), regardless of the duration of symptoms (less than or more than 24 hours). Sudden onset of focal neurological symptoms lasting more than 24 hours, with no apparent cause other than cerebral ischemia. Intracerebral hemorrhage: sudden onset of focal neurological symptoms with the presence of cerebral hemorrhage in the appropriate territory on brain imaging (CT or MRI), regardless of the duration of symptoms (less than or more than 24 hours) and regardless of the cause of the hemorrhage (spontaneous or secondary to trauma, tumour or another cause). Unknown type of stroke : the type of stroke cannot be determined with certainty and the symptoms last more than 24 hours.

Secondary Outcome Measures

Time to disabling stroke

mRS score greater than or equal to 3, with an increase of at least 2 points compared to the last mRS score before the stroke.

Time to ischemic stroke

At least one of the following criteria: Sudden onset of focal neurological symptoms with the presence of cerebral infarction in the appropriate territory on brain imaging (CT or MRI), regardless of the duration of symptoms (less than or more than 24 hours). Sudden onset of focal neurological symptoms lasting more than 24 hours, with no apparent cause other than cerebral ischemia.

Time to ischemic stroke or systemic embolism

Clinical features related to embolism usually affecting a limb, mesenteric, splenic, or renal artery. The diagnosis of embolism must be confirmed by appropriate investigations.

Time to transient ischemic attack,

Sudden onset of neurological symptoms, presumed to be ischemic, resolving in less than 24 hours, clearly attributable to focal involvement of the central nervous system (or of the eye) with no signs of a corresponding recent cerebral infarction on brain imaging. The diagnosis of TIA will be confirmed by a neurologist, considering clinical data and brain imaging (MRI with diffusion sequence is recommended).

Time to vascular death

death related to a cardiac or vascular cause. death due to hemorrhage. death due to pulmonary embolism. sudden death: death occurring in less than 24 hours, unexpectedly in a subject in apparent good health and whose condition was stable or was improving. death with no documented non-vascular cause. fatal stroke: death occurring within 30 days of a stroke (ischemic or hemorrhagic).

Time to all-cause mortality

Vascular (see definition) or nonvascular death: death due to a documented non-vascular cause (infection, cancer, accident, suicide, etc.).

Quality of life score

Measured by using the European Quality Of Life (EQ-5D) auto-questionnaire. The digits for the five dimensions are combined into a 5-digit number that describes the patient's health state. The visual analogue scale (VAS) records the patient's self-rated health on a vertical axis from 0 (worst health) to 100 (best health)

Time to fatal, life-threatening or major hemorrhage, including intracerebral and Intracranial hemorrhage

Life-threatening Fatal hemorrhage. Drop in hemoglobin by ≥ 5 g/dL (or drop in hematocrit by 15% or more in absolute value) Symptomatic intracranial hemorrhage (confirmed by appropriate investigations, classified as cerebral hemorrhage, subarachnoid hemorrhage and subdural hematoma). Transfusion ≥ 4 units of packed cells (or equivalent of whole blood)*. Major Transfusion ≤ 3 units of packed cells (or equivalent of whole blood)*. Requiring hospitalization (or prolonging hospitalization). Requiring surgical treatment. Intraocular hemorrhage with significant loss of vision. Other hemorrhage responsible for significant disability according to the investigator.

Proportion of success of device implantation, of the procedure and of PFO closure,

Success of device implantation: deployment of the device in the appropriate place and removal of the placement system. Success of the procedure: successful implantation with no complications before the patient's discharge. Success of PFO closure: success of the procedure with no residual shunt or minimal residual shunt on echocardiography performed 6 months after the procedure.

Time to ischemic stroke recurrence according to the presence of a residual shunt

From control echocardiography after PFO closure to the end of the patient's follow-up

Time to new-onset atrial fibrillation

Atrial fibrillation lasting at least 30 seconds

Proportion of fatal, life-threatening or major procedure- or device-related complications

Life-threatening Cardiac perforation with tamponade requiring emergency drainage. Cerebral air embolism responsible for acute neurological disorders Embolization of the device. Life-threatening hematoma at the puncture site or retroperitoneal. Complications of general anesthesia or TOE requiring intensive care and/or surgical operation. Major Hemorrhage at the puncture site or retroperitoneal requiring transfusion or surgery. Arteriovenous fistula, pseudoaneurysm requiring surgery. Peripheral nerve lesion with disabling neurological deficit persisting > 1 month. Cardiac arrhythmias (particularly AF) during catheterization or post-procedure requiring treatment >= 1 month. Infective endocarditis. Asymptomatic late thrombosis of the device. Any device-related complication requiring surgery. Any other complication related to the transcatheter treatment or anesthesia, considered to be major by the investigator.

Costs

Costs will be estimated from the viewpoint of the healthcare system (hospital admission, transportation, study interventions, emergency room visit without admission,consultations,imaging)

Incremental cost-utility ratio at 4 years (ICUR)

The incremental cost-utility ratio (ICUR) will be calculated as difference in costs (between groups)/difference in QALYs (Quality-Adjusted Life Year) between groups. The QALYs will be constructed with the EuroQoL-5D (EQ-5D) questionnaire and value sets

Full Information

NCT ID

NCT05387954

First Posted

May 4, 2022

Last Updated

May 20, 2022

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Ministry of Health, France, W.L.Gore & Associates, Abbott, Occlutech International AB, Centre Hospitalier St Anne

1. Study Identification

Unique Protocol Identification Number

NCT05387954

Brief Title

PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years

Acronym

CLOSE-2

Official Title

Transcatheter Patent Foramen Ovale (PFO) Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Between 60 and 80 Years Old : a Randomised Controlled Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

June 1, 2022 (Anticipated)

Primary Completion Date

June 1, 2030 (Anticipated)

Study Completion Date

June 1, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Ministry of Health, France, W.L.Gore & Associates, Abbott, Occlutech International AB, Centre Hospitalier St Anne

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To assess whether PFO closure plus antiplatelet therapy is superior to antiplatelet therapy alone and whether oral anticoagulant therapy is superior to antiplatelet therapy to prevent stroke recurrence in patients aged 60 to 80 years with a PFO with large shunt (> 20 microbubbles) or a PFO associated with an ASA (> 10 mm), and an otherwise unexplained ischemic stroke.

Detailed Description

The CLOSE trial (NCT00562289, NEJM 2017) has unambiguously demonstrated the superiority of patent foramen ovale (PFO) closure over antiplatelet therapy alone in patients aged up to 60 years with a PFO associated with an atrial septal aneurysm (ASA) or a large right-to-left shunt (so-called "high-risk PFO"), and an otherwise unexplained ischemic stroke. Oral anticoagulant therapy is also a logical approach assuming that PFO-related strokes are due to paradoxical embolism which implies a venous source of embolism, or to direct embolization of a thrombus formed at the atrial level. The CLOSE trial also suggested that oral anticoagulants might reduce stroke recurrence compared to aspirin. There is accumulating evidence that presence of a PFO is significantly associated with cryptogenic stroke in patients over 60 years. Cryptogenic ischemic strokes represent about one third of all ischemic strokes in patients older than 60 years. However, the optimal therapeutic strategy in patients older than 60 years with a PFO and an otherwise unexplained ischemic stroke is unknown, because these patients were excluded from randomized trials. The hypothesis tested in this trial is that transcatheter PFO closure plus long-term antiplatelet therapy is superior to antiplatelet therapy alone and that oral anticoagulant therapy is superior to antiplatelet therapy to prevent recurrent stroke in patients aged 60 to 80 years who have a high-risk PFO and a recent otherwise unexplained ischemic stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cryptogenic Ischemic Stroke, Patent Foramen Ovale

Keywords

Ischemic stroke, Cryptogenic stroke, Patent foramen ovale, Atrial septal aneurysm, Transcatheter PFO closure, Oral anticoagulants, Antiplatelet therapy, Randomized clinical tria

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

PFO closure + antiplatelet therapy versus antiplatelet therapy alone Oral anticoagulants versus antiplatelet therapy

Masking

Outcomes Assessor

Masking Description

The clinical event adjudication committee will blind to the treatment allocated by randomization.

Allocation

Randomized

Enrollment

792 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Antiplatelet therapy

Arm Type

Active Comparator

Arm Description

Aspirin OR clopidogrel

Arm Title

Oral anticoagulants, Direct-Acting

Arm Type

Experimental

Arm Description

Apixaban (5mg twice a day) OR Dabigatran (150 mg twice a day) OR Rivaroxaban (20 mg once a day)

Arm Title

PFO closure

Arm Type

Experimental

Arm Description

PFO closure followed by dual antiplatelet therapy (aspirin 75 mg/d + clopidogrel 75 mg/d) for 3 months, then by single antiplatelet therapy by aspirin or clopidogrel

Intervention Type

Procedure

Intervention Name(s)

Transcatheter PFO closure

Other Intervention Name(s)

•Each device for PFO closure must have the CE mark, •and be approved by the Interventional Cardiology Committee

Intervention Description

PFO closure followed by dual antiplatelet therapy (aspirin 75 mg/d + clopidogrel 75 mg/d) for 3 months, then by single antiplatelet therapy by aspirin or clopidogrel until the end of the study.

Intervention Type

Drug

Intervention Name(s)

Oral Anticoagulant, Direct-Acting

Intervention Description

Apixaban (5mg twice a day) OR Dabigatran (150 mg twice a day) OR Rivaroxaban (20 mg once a day)

Intervention Type

Drug

Intervention Name(s)

Antiplatelet therapy

Intervention Description

Patients randomized to this arm will receive antiplatelet therapy throughout the study : aspirin 75 mg/d + clopidogrel 75 mg/d) for 3 months, then single antiplatelet therapy by aspirin or clopidogrel

Primary Outcome Measure Information:

Title

Time to recurrent stroke (ischemic or hemorrhagic fatal or non-fatal)

Description

Time Frame

From date of randomization until the date of first recurrent stroke, assessed from up to 4 years (for the last patient included) to up to 8 years (for the first patient included)

Secondary Outcome Measure Information:

Title

Time to disabling stroke

Description

mRS score greater than or equal to 3, with an increase of at least 2 points compared to the last mRS score before the stroke.

Time Frame

From date of randomization until the date of first recurrent disabling stroke, assessed from up to 4 years (for the last patient included) to up to 8 years (for the first patient included)

Title

Time to ischemic stroke

Description

Time Frame

From date of randomization until the date of first recurrent ischemic stroke, assessed from up to 4 years (for the last patient included) to up to 8 years (for the first patient included)

Title

Time to ischemic stroke or systemic embolism

Description

Clinical features related to embolism usually affecting a limb, mesenteric, splenic, or renal artery. The diagnosis of embolism must be confirmed by appropriate investigations.

Time Frame

From date of randomization until the date of first recurrent ischemic stroke or systemic embolism, assessed from up to 4 years (for the last patient included) to up to 8 years (for the first patient included)

Title

Time to transient ischemic attack,

Description

Time Frame

From date of randomization until the date of first transient ischemic attack, assessed from up to 4 years (for the last patient included) to up to 8 years (for the first patient included)

Title

Time to vascular death

Description

Time Frame

From date of randomization until the date of vascular death, assessed from up to 4 years (for the last patient included) to up to 8 years (for the first patient included)

Title

Time to all-cause mortality

Description

Vascular (see definition) or nonvascular death: death due to a documented non-vascular cause (infection, cancer, accident, suicide, etc.).

Time Frame

From date of randomization until the date of death, assessed from up to 4 years (for the last patient included) to up to 8 years (for the first patient included)

Title

Quality of life score

Description

Time Frame

Every 6 months after randomization or up to 4 years (for the last patient included) to up to 8 years (for the first patient included)]

Title

Time to fatal, life-threatening or major hemorrhage, including intracerebral and Intracranial hemorrhage

Description

Time Frame

From date of randomization until the date of first fatal,life-threatening or major hemorrhage,including intracerebral and Intracranial hemorrhage,assessed from up to 4 years(for the last patient included) to up to 8 years(for the first patient included)

Title

Proportion of success of device implantation, of the procedure and of PFO closure,

Description

Time Frame

6 months after PFO closure

Title

Time to ischemic stroke recurrence according to the presence of a residual shunt

Description

From control echocardiography after PFO closure to the end of the patient's follow-up

Time Frame

From date of PFO closure until the date of first ischemic stroke recurrence, assessed from up to 4 years (for the last patient included) to up to 8 years (for the first patient included), according to the presence of residual shunt]

Title

Time to new-onset atrial fibrillation

Description

Atrial fibrillation lasting at least 30 seconds

Time Frame

From date of randomization until the date of new-onset atrial fibrillation, assessed from up to 4 years (for the last patient included) to up to 8 years (for the first patient included)]

Title

Proportion of fatal, life-threatening or major procedure- or device-related complications

Description

Time Frame

Within 4 weeks following the procedure (PFO closure)

Title

Costs

Description

Costs will be estimated from the viewpoint of the healthcare system (hospital admission, transportation, study interventions, emergency room visit without admission,consultations,imaging)

Time Frame

Within 48 months after randomization

Title

Incremental cost-utility ratio at 4 years (ICUR)

Description

Time Frame

Within 48 months after randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Man or woman aged 60 to 80 years. Recent (≤ 6 months) ischemic stroke confirmed by cerebral imaging regardless of symptom duration. Absence of a more probable cause of stroke than PFO after a standardized etiological work-up (see addenda). Presence of a PFO with at least 1 of the 2 following characteristics: PFO with large shunt (> 20 microbubbles appearing inthe left atrium within 3 cardiac cycles after opacification of the right atrium) detected spontaneously or during provocative maneuvers, PFO with ASA on transesophageal echocardiography (TOE): base of aneurysm >= 15mm and excursion >10 mm. Affiliation to a French Health Insurance system. Informed consent. Exclusion Criteria: Life expectancy < 4 years. Contraindication to both experimental treatments (PFO closure, oral anticoagulant therapy) or to the reference treatment (antiplatelet therapy) (see paragraph 19.5). Indication to long-term anticoagulant therapy. mRS >= 3. Presence of other medical conditions that would lead to inability to complete the study or interfere with the assessment of outcomes. Previous surgical or transcatheter treatment of PFO or ASA. Expected impossible follow-up or poor compliance. Patient unable to understand the informed consent form. Patient under tutorship, curatorship, or legal protection.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Aurélie Guimfack

Phone

+331 44 84 17 98

aurelie.guimfack@aphp.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Malha Berrah

malha.berrah@aphp.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Louis Mas, MD

Organizational Affiliation

GHU Psychiatrie et Neurosciences Paris

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gilles Chatellier, MD

Organizational Affiliation

Hôpital Européen Georges-Pompidou

Official's Role

Study Director

Facility Information:

Facility Name

CHU Amiens

City

Amiens

ZIP/Postal Code

80054

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sandrine Canaple, MD

Facility Name

CH Arras

City

Arras

ZIP/Postal Code

62022

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Patrick Le-Coz, MD

Facility Name

CHU Jean Minjoz

City

Besançon

ZIP/Postal Code

25000

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fabrice Vuillier, MD

Facility Name

CHU Bordeaux - GH Pellegrin

City

Bordeaux

ZIP/Postal Code

33000

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pauline Renou, MD

Facility Name

CHRU La Cavale Blanche

City

Brest

ZIP/Postal Code

29200

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Serge Timsit, MD

Facility Name

HCL-Groupement Hospitalier Lyon Est

City

Bron

ZIP/Postal Code

69677

Country

France

Facility Name

CHU Côte de Nacre

City

Caen

ZIP/Postal Code

14000

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emmanuel Touzé, MD

Facility Name

Hôpital Henri Mondor

City

Créteil

ZIP/Postal Code

94010

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hassan Hosseini, MD

Facility Name

CHU Dijon-Hôpital François Mitterrand

City

Dijon

ZIP/Postal Code

21079

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yannick Béjot, MD

Facility Name

CH Grenoble-Site Nord

City

Grenoble

ZIP/Postal Code

38043

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Isabelle Favre Wiki, MD

Facility Name

CH Versailles-Hôpital Mignot

City

Le Chesnay

ZIP/Postal Code

78150

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fernando Pico, MD

Facility Name

CHU Bicêtre

City

Le Kremlin-Bicetre

ZIP/Postal Code

94370

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christian Denier, MD

Facility Name

CHRU Lille-Hôpital Salengro

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nelly Dequatre, MD

Facility Name

Hôpital de la Timone

City

Marseille

ZIP/Postal Code

13005

Country

France

Facility Name

Hôpital Gui de Chauliac

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

CHRU Nancy-Hôpital central

City

Nancy

ZIP/Postal Code

54035

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sébastien Richard, MD

Facility Name

CHU Carémeau

City

Nîmes

ZIP/Postal Code

30900

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anne Wacongne, MD

Facility Name

APHP Hôpital Lariboisière

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peggy Reiner, MD

Facility Name

Hôpital Pitié Salpêtrière

City

Paris

ZIP/Postal Code

75013

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sonia Alamowitch, MD

Facility Name

GHU Paris Psychiatrie et Neurosciences

City

Paris

ZIP/Postal Code

75014

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guillaume Turc, MD

Facility Name

Groupe Hospitalier Paris Saint-Joseph

City

Paris

ZIP/Postal Code

75014

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mathieu Zuber, MD

Facility Name

APHP Hôpital Bichat

City

Paris

ZIP/Postal Code

75018

Country

France

Facility Name

Fondation Adolphe de Rothschild

City

Paris

ZIP/Postal Code

75019

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michaël Obadia, MD

Facility Name

CH Perpignan

City

Perpignan

ZIP/Postal Code

66000

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Denis Sablot, MD

Facility Name

CHU La Milétrie

City

Poitiers

ZIP/Postal Code

86021

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean-Philippe Neau, MD

Facility Name

CHU Rouen-Hôpital Charles-Nicolle

City

Rouen

ZIP/Postal Code

76000

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Evelyne Guegan-Massardier, MD

Facility Name

CH Yves Le Foll

City

Saint Brieuc

ZIP/Postal Code

22000

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Grégory Couvreur, MD

Facility Name

CHU Nantes-Hôpital Nord Laennec

City

Saint Herblain

ZIP/Postal Code

44093

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Benoit guillon, MD

Facility Name

CHU Saint-Etienne-Hôpital Nord

City

Saint-Priest en Jarez

ZIP/Postal Code

42270

Country

France

Facility Name

Hôpital Hautepierre

City

Strasbourg

ZIP/Postal Code

67000

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wolff Wolff, MD

Facility Name

CHU Toulouse-Hôpital Pierre Paul Riquet

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicolas Rasposo, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

IPD Sharing Time Frame

Two years after the last publication

IPD Sharing Access Criteria

Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and PI team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasability and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Learn more about this trial

PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years

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PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years (CLOSE-2)

Cryptogenic Ischemic Stroke, Patent Foramen Ovale

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial