UMIN-CTR Clinical Trial

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

acute coronary syndrome

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

jamkuhta@yahoo.co.jp

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

Email

jamkuhta@yahoo.co.jp

Institute

Okayama City Hospital

Institute

Department

Personal name

Organization

Cardiovascular Medicine,Okayama University Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Okayama City Hospital

Address

3-20-1, Omote-cho, Kitanagase, Okayama 700-8557, Japan

Tel

086-737-3000

Email

jamkuhta@yahoo.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

12

Month

01

Day

URL releasing protocol

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9715828/

Publication of results

Partially published

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

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 related 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