Ignite Creation Date:
2024-05-06 @ 4:25 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04971356
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-14
First Post:
2021-07-20
Brief Title:
1-month DAPT Plus 5-month Ticagrelor Monotherapy Versus 12-month DAPT in Patients With Drug-coated Balloon
Sponsor:
Xijing Hospital
Organization:
Xijing Hospital
Study Overview
Official Title:
Aspirin Plus Ticagrelor for 1 Month Followed by 5 Months Ticagrelor Monotherapy Versus Aspirin Plus Ticagrelor for 12 Months in Acute Coronary Syndrome Patients With Drug-coated Balloon a Multicentre Randomized Non-inferiority Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
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:
CAGEFREEII
Brief Summary:
Drug-Coated Balloon DCB angioplasty is similar to plain old balloon angioplasty procedurally but there is an anti-proliferative medication paclitaxel coated to the balloon Treating ISR lesions with the DCB has the theoretical advantage of avoiding multiple stent layers and respecting the vessel anatomy DCB has shown promising results for the treatment of ISR Currently DCB has a Class I indication to treat ISR recommended by European Society of Cardiology guidelines In addition some interventional cardiologist has also applied DCB in de novo lesions in their clinical practice
Bleeding after PCI remains a substantial clinical problem Bleeding post-PCI increases the risk of adverse outcomes such as death non-fatal myocardial infarction and prolongs hospital stay Clinical data has suggested that major bleeding post-PCI would increase the risk of mortality 57-fold The antiplatelet medications are the major cause of bleeding events post-PCI
Current guidelines for stents recommended DAPT of aspirin plus a P2Y12 inhibitor for at least 12 months after stent implantation in patients with the acute coronary syndrome Compared with the DES because of the absence of metal inside the coronary artery the use of DCB might theoretically allow shorter duration antiplatelet therapy However the optimal course of DAPT for the DCB treated patients remains controversial
In 2013 the consensus from the German group suggested that for the acute coronary syndrome DAPT should be used for 12 months The consensus of DAPT developed by the European Society of Cardiology ESC in 2017 stated that in patients treated with DCB dedicated clinical trials investigating the optimal duration of DAPT are lacking So far there are no randomized data showing the optimal DAPT duration for the DCB treated patients
In the current study we use Aspirin Ticagrelor for 1-month followed by Ticagrelor monotherapy for 5-month afterward Aspirin monotherapy for 6 months to be the antiplatelet regimen in the experimental arm to compare with the Reference arm which is Aspirin Ticagrelor for 12-month in a non-inferiority statistical assumption aiming to investigate the optimal duration of the DAPT in ACS patients after DCB treatment
Bleeding after PCI remains a substantial clinical problem Bleeding post-PCI increases the risk of adverse outcomes such as death non-fatal myocardial infarction and prolongs hospital stay Clinical data has suggested that major bleeding post-PCI would increase the risk of mortality 57-fold The antiplatelet medications are the major cause of bleeding events post-PCI
Current guidelines for stents recommended DAPT of aspirin plus a P2Y12 inhibitor for at least 12 months after stent implantation in patients with the acute coronary syndrome Compared with the DES because of the absence of metal inside the coronary artery the use of DCB might theoretically allow shorter duration antiplatelet therapy However the optimal course of DAPT for the DCB treated patients remains controversial
In 2013 the consensus from the German group suggested that for the acute coronary syndrome DAPT should be used for 12 months The consensus of DAPT developed by the European Society of Cardiology ESC in 2017 stated that in patients treated with DCB dedicated clinical trials investigating the optimal duration of DAPT are lacking So far there are no randomized data showing the optimal DAPT duration for the DCB treated patients
In the current study we use Aspirin Ticagrelor for 1-month followed by Ticagrelor monotherapy for 5-month afterward Aspirin monotherapy for 6 months to be the antiplatelet regimen in the experimental arm to compare with the Reference arm which is Aspirin Ticagrelor for 12-month in a non-inferiority statistical assumption aiming to investigate the optimal duration of the DAPT in ACS patients after DCB treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None