UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029729 |
|---|---|
| Receipt number | R000033968 |
| Scientific Title | Correlation between High Platelet Reactivity with Loading Dose of Prasugrel and Clinical Outcome in the Patients with Acute Coronary Syndrome |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2023/10/31 13:39:59 |
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Basic information
Public title
Correlation between High Platelet Reactivity with Loading Dose of Prasugrel and Clinical Outcome in the Patients with Acute Coronary Syndrome
Acronym
Correlation between High Platelet Reactivity with Loading Dose of Prasugrel and Clinical Outcome in the Patients with Acute Coronary Syndrome
Scientific Title
Correlation between High Platelet Reactivity with Loading Dose of Prasugrel and Clinical Outcome in the Patients with Acute Coronary Syndrome
Scientific Title:Acronym
Correlation between High Platelet Reactivity with Loading Dose of Prasugrel and Clinical Outcome in the Patients with Acute Coronary Syndrome
Region
| Japan |
Condition
Condition
acute coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the correlation between HPR in the early phase of ACS with loading dose of prasugrel and clinical outcome
Basic objectives2
Others
Basic objectives -Others
Evaluation of pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
composite of all death, myocardial death, myocardial infarction, stroke, ventricular arrhythmia needing defibrillation, cardiac rupture and serious hemorrhage within 30 days of onset
Key secondary outcomes
composite of all death, myocardial death, myocardial infarction, stroke, heart-failure hospitalization, target lesion revascularization and serious hemorrhage within one year of onset
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Prasugrel 20mg
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(a) patients with acute coronary syndrome to whom emergent PCI is planned.
(b)patients aged over 20 and under 90 years old.
Key exclusion criteria
(a) patients wiht bleeding tendency
(b) patients with allagy against thienopyridine drugs
(c)patients who are not suitable for this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | yusuke |
| Middle name | |
| Last name | kawai |
Organization
okayama city hospital
Division name
Department of Cardiovascular Medicine
Zip code
700-8557
Address
3-20-1, Omote-cho, Kitanagase, Okayama 700-8557, Japan
TEL
086-737-3000
jamkuhta@yahoo.co.jp
Public contact
Name of contact person
| 1st name | yusuke |
| Middle name | |
| Last name | kawai |
Organization
Okayama City Hospital
Division name
Department of Cardiovascular Medicine
Zip code
700-8557
Address
3-20-1, Omote-cho, Kitanagase, Okayama 700-8557, Japan
TEL
086-737-3000
Homepage URL
jamkuhta@yahoo.co.jp
Sponsor or person
Institute
Okayama City Hospital
Institute
Department
Personal name
Funding Source
Organization
Cardiovascular Medicine,Okayama University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama City Hospital
Address
3-20-1, Omote-cho, Kitanagase, Okayama 700-8557, Japan
Tel
086-737-3000
jamkuhta@yahoo.co.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9715828/
Publication of results
Partially published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9715828/
Number of participants that the trial has enrolled
182
Results
Left ventricular remodeling (LVR) in the chronic phase was found in 34 patients (18.7%) whose platelet reactivity was significantly higher than those without LVR (260PRU vs. 213PRU, P=0.001). Left ventricular end-diastole volume index (LVEDVI) significantly decreased at the chronic phase in patients without high platelet reactivity (HPR), but not in patients with HPR. Multivariate logistic analysis showed that HPR was an independent predictor of LVR (OR 4.13, 95%CI 1.85-9.79).
Results date posted
| 2023 | Year | 10 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients hospitalized for acute coronary syndrome (ACS) and who underwent primary PCI were prospectively enrolled.
The exclusion criteria were as follows: age less than 18 years, death during hospitalization, lack of platelet reactivity data, lack of appropriate echocardiographic data during hospitalization, and cases with echo data outside the follow-up period or cases where echocardiographic follow-up was not performed.
Participant flow
A total of 349 patients with AMI who underwent index PCI between January 2016 and June 2021 were identified from the hospital. After screening, 182 patients were included in the study. Platelet reactivity could not be measured in 36 patients because of hemodynamic instability or urgent treatment. Moreover, there were no available echocardiographic data in 32 patients, and 8 patients died during hospitalization. Therefore, these patients were excluded, and 273 patients remained in the initial cohort. Of these, appropriate echocardiographic data could not be acquired in 42 patients. Additionally, 49 patients could not undergo echocardiography within the designated period because of deterioration in activities or hospitalization in other institutions. The remaining 182 participants were enrolled in the study.
Adverse events
No adverse events were associated with the study because it is an observational study.
Outcome measures
In the HPR group, LVEF was significantly increased in the chronic phase (58.3% vs. 60.6%, P=0.013), while LVEDVI, LVESVI, LAVI, LVMI, and E/e did not change. In contrast, in the non-HPR group, LVEF was increased (60.3% vs. 62.9%, P=0.005), and LVEDVI (49.2 vs.45.4 ml/m2, P=0.020), LVESVI (20.0 vs. 16.8 ml/m2, P<0.001), LVMI (106.9 vs. 98.9, P=0.003), and E/e (13.4 vs. 11.9, P<0.001), were significantly decreased.
The univariate logistic analysis demonstrated that the presence of LVR was significantly associated with LVEDVI (OR 4.56, 95%CI 2.08-10.7, P<0.001) and HPR (OR 0.95, 95%CI 0.92-0.99, P=0.009). The multivariate logistic analysis also showed that the presence of LVR was significantly associated with LVEDVI (OR 0.96, 95%CI 0.92-0.99, P=0.026) and HPR (OR 4.13, 95%CI 1.85-9.79, P<0.001).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 26 | Day |
Last modified on
| 2023 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033968
