Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-25 @ 3:17 PM
Study NCT ID:
NCT04795492
Status:
WITHDRAWN
Last Update Posted:
2024-02-08
First Post:
2021-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Remote Intervention in Patients With SCAD
Sponsor:
Chinese Academy of Medical Sciences, Fuwai Hospital
Organization:
Study Overview
Official Title:
Effect of Remote Intervention in Patients With SCAD
Status:
WITHDRAWN
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit enough patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study was a multicenter, two-arm, parallel, open-label, prospective clinical trial that evaluated a remote intervention with 1 year of follow-up.
Detailed Description:
Objective: This study is intended to verify the effect of a remote intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease.
Study design: The study was a multicenter, two-arm, parallel, open-label, prospective clinical trial that evaluated the effect of a remote intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease with 1 year of follow-up.
Study intervention: Participants in the experimental group received remote guidance from the cardiac rehabilitation team in the community hospital every month after enrollment. The control group had no special intervention. All patients received follow-up at 6 months and 1-year follow-up.
Outcome measures: The primary outcome was medication adherence. Secondary outcomes included smoking, drinking, blood pressure, body mass index, LDL cholesterol, HbA1c, and major adverse cerebral cardiovascular events(MACCE). Medication compliance consists of the following five medications: aspirin, P2Y12 receptor antagonist, statin, ACEI/ARB and beta-blocker.
Statistical analysis: Values of analyzed endpoints between intervention group and control group will be compared according to the analysis plan. We'll follow a prespecified analysis plan and subgroup analysis will be conducted accordingly.
Study design: The study was a multicenter, two-arm, parallel, open-label, prospective clinical trial that evaluated the effect of a remote intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease with 1 year of follow-up.
Study intervention: Participants in the experimental group received remote guidance from the cardiac rehabilitation team in the community hospital every month after enrollment. The control group had no special intervention. All patients received follow-up at 6 months and 1-year follow-up.
Outcome measures: The primary outcome was medication adherence. Secondary outcomes included smoking, drinking, blood pressure, body mass index, LDL cholesterol, HbA1c, and major adverse cerebral cardiovascular events(MACCE). Medication compliance consists of the following five medications: aspirin, P2Y12 receptor antagonist, statin, ACEI/ARB and beta-blocker.
Statistical analysis: Values of analyzed endpoints between intervention group and control group will be compared according to the analysis plan. We'll follow a prespecified analysis plan and subgroup analysis will be conducted accordingly.
Study Oversight
Has Oversight DMC:
True
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?: