Ignite Creation Date:
2024-05-06 @ 7:50 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02611973
Status:
UNKNOWN
Last Update Posted:
2017-07-26
First Post:
2015-10-13
Brief Title:
Hydroxyurea Versus Aspirin and Hydroxyurea in Essential Thrombocythemia
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
French Aspirin Study in Essential Thrombocythemia an Open and Randomized Study
Status:
UNKNOWN
Status Verified Date:
2017-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FAST
Brief Summary:
The hypothesis is that efficient prevention of thrombosis with aspirin at diagnosis becomes less useful once patients have achieved a hematologic response HR modified by amendment 1032017 andor that this benefit is hampered by an increased hemorrhagic risk especially in elderly patients
Hence investigator propose a prospective randomized study to assess the benefit risk ratio of aspirin maintenance in high risk Essential thrombocythemia ET patients in hematological response modified by amendment 1032017 on Hydroxyurea
Hence investigator propose a prospective randomized study to assess the benefit risk ratio of aspirin maintenance in high risk Essential thrombocythemia ET patients in hematological response modified by amendment 1032017 on Hydroxyurea
Detailed Description:
ET is a myeloproliferative neoplasm MPN characterized by a high platelet level Increased occurrence of thrombosis and hemorrhages are the main complications in ET In this regard the key factors defining high risk ET include age over 60 years past history of thrombosis platelet 1500 109L and to a lesser degree cardiovascular risk factors These criteria currently serve as therapeutic guidelines for the use of cytoreductive therapy with hydroxyurea HU being the treatment of choice in the first line setting
The use of antiplatelet agent ie low-dose aspirin is also generally recommended However the benefit of aspirin has never been formally demonstrated in ET Only indirect evidence come from the ECLAP study that enrolled patients with polycythemia vera PV Of note in the ECLAP study the efficacy of aspirin was assessed only at diagnosis but not correlated thereafter with the hematological response on cytoreductive therapy
In general non-MPN population studies primary prophylaxis with aspirin has been associated with a risk reduction of major vascular events but an increased risk of hemorrhage especially considering age and prior gastrointestinal history In a recent retrospective study the combination of aspirin and cytoreduction was reported to prevent thrombosis but concomitantly increase the bleeding risk when compared to HU alone especially in patients older than 60 years thus questioning the benefits of long term use of aspirin therapy These data raise the question of the actual benefit of aspirin maintenance once patients have been efficiently treated with cytoreductive therapy
Hence investigator propose a prospective randomized study to assess the benefit risk ratio of aspirin maintenance in high risk ET patients in hematological response modified by amendment 1032017 on Hydroxyurea Patients for which Aspirin interruption will not be possible because of extra-ET indications will be enrolled in the control observational arm
The use of antiplatelet agent ie low-dose aspirin is also generally recommended However the benefit of aspirin has never been formally demonstrated in ET Only indirect evidence come from the ECLAP study that enrolled patients with polycythemia vera PV Of note in the ECLAP study the efficacy of aspirin was assessed only at diagnosis but not correlated thereafter with the hematological response on cytoreductive therapy
In general non-MPN population studies primary prophylaxis with aspirin has been associated with a risk reduction of major vascular events but an increased risk of hemorrhage especially considering age and prior gastrointestinal history In a recent retrospective study the combination of aspirin and cytoreduction was reported to prevent thrombosis but concomitantly increase the bleeding risk when compared to HU alone especially in patients older than 60 years thus questioning the benefits of long term use of aspirin therapy These data raise the question of the actual benefit of aspirin maintenance once patients have been efficiently treated with cytoreductive therapy
Hence investigator propose a prospective randomized study to assess the benefit risk ratio of aspirin maintenance in high risk ET patients in hematological response modified by amendment 1032017 on Hydroxyurea Patients for which Aspirin interruption will not be possible because of extra-ET indications will be enrolled in the control observational arm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None