UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056844 |
|---|---|
| Receipt number | R000064967 |
| Scientific Title | Goal of Dynamic Strategy by Aggressive Lipid Intervention in Acute Myocardial Infarction |
| Date of disclosure of the study information | 2025/02/02 |
| Last modified on | 2025/01/28 16:44:41 |
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Basic information
Public title
Goal of Dynamic Strategy by Aggressive Lipid Intervention in Acute Myocardial Infarction
Acronym
GOODBYLIPID-AMI
Scientific Title
Goal of Dynamic Strategy by Aggressive Lipid Intervention in Acute Myocardial Infarction
Scientific Title:Acronym
GOODBYLIPID-AMI
Region
| Japan |
Condition
Condition
Acute Myocardial Infarction
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of lipid-lowering therapy for residual coronary plaque in patients undergoing percutaneous coronary intervention by cardiac catheter for acute myocardial infarction
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Since this is an exploratory study to determine the efficacy of lipid-lowering therapy for residual coronary plaque in non-culprit lesions in patients undergoing PCI for AMI, the principal investigator or investigators will determine the endpoints and analysis methods after data collection.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following eligibility criteria
(1) 18 years of age or older and less than 85 years of age
(2) Have one of the following residual lesions at the time of PCI for AMI
i) Coronary angiographic stenosis between 25% and 75%.
ii) Coronary angiographic stenosis of 75% to less than 90% and FFR >0.80 or Resting Index >0.89
(3) Fasting LDL-C level >55 mg/dL during hospitalization
(4) Written consent for participation in the study is obtained from the patient.
Key exclusion criteria
(1) eGFR<30 ml/min/1.73m2
(2) Current or historical use of PCSK9 inhibitors or sustained LDL-C-lowering siRNA agents
(3) Scheduled PCI or CABG for residual coronary artery lesions under study
(4) Complicated congenital heart disease
(5) Patients with a permanent pacemaker or internal defibrillation leads
(6) Patients after artificial heart valve replacement
(7) Patients with arrhythmia or tachycardia that interferes with CT data acquisition
(8) Patients with body mass index (BMI) >35
(9) Patients with contraindication to nitrates
(10) Patients with no prognosis for more than 1-year
(11) Patients who participated in clinical trials with other drugs
(11) Patients participating in clinical trials with other drugs
(12) Patients under conditions that may interfere with patient safety or protocol compliance
(13) Patients who are deemed unsuitable by the principal investigator or sub investigator
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Ueda |
Organization
Nara Medical University
Division name
Department of Cardiovascular Medicine
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara, Japan
TEL
0744-22-3051
tom15@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazutaka |
| Middle name | |
| Last name | Nogi |
Organization
Nara Medical University
Division name
Department of Cardiovascular Medicine
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara, Japan
TEL
0744-22-3051
Homepage URL
nogi18kazu@dream.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University Research Ethics Committee
Address
840 Shijo-cho, Kashihara, Nara, Japan
Tel
0744-22-3051
ino_rinri@naramed-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
奈良県立医科大学附属病院、奈良県総合医療センター、奈良県西和医療センター、市立奈良病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluate the efficacy of lipid-lowering therapy for residual coronary plaque in patients undergoing percutaneous coronary intervention by cardiac catheter for acute myocardial infarction
Management information
Registered date
| 2025 | Year | 01 | Month | 28 | Day |
Last modified on
| 2025 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064967
