Cerebral Infarction, Ischemic Symptoms
Conditions
Brief summary
This is a Post Marketing Observational Study of cilostazol (Pletaal® SR capsule). As this study is observational in nature to collect the safety data after administrating the Pletaal SR capsule, from baseline to 16 weeks.
Detailed description
This study will be conducted in a prospective, single-arm, multi-center format. As this study is observational in nature, the patient's follow-up is not prescriptive in nature and must be left up to the judgment of the physician (investigator), within the period of observation set forth in the protocol.
Interventions
OTHERThis is Non-interventional study
Sponsors
Korea Otsuka Pharmaceutical Co., Ltd.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study : 1. Patients who are prescribed Pletaal® SR capsule treatment as per investigator's medical judgment for adults aged 19 and over. 2\. Patients who gave written authorization to use their personal and health data Physician (Investigator) will refer to the product market authorization (package insert) for inclusion criteria.
Exclusion criteria
* Patients presenting with any of the following will not be included in the study 1. Patients with hemorrhage 2. Patients with congestive heart failure 3. Patients with known hypersensitivity to Cilostazole or any ingredients of Pletaal® 4. Women who are pregnant or may possibly become pregnant 5. Patients who is not eligible to participate this study as investigator's medical judgment Physician (Investigator) will refer to the product market authorization (package insert) for
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Incidence Rate and the Number of AE/ADRs | Follow-up at least once from baseline to 16 weeks | Incidence rates of overall AEs and ADRs that occurred during the study period |
Secondary
| Measure | Time frame |
|---|---|
| The Incidence Rate of Tarchycardia and Palpitation After Pletaal® SR Capsule Administration | Follow-up at least once from baseline to 16 weeks |
| The Number and Percentage of Drop-out Patients According to Aes | Follow-up at least once from baseline to 16 weeks |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pletaal® SR Capsule Subjects who received at least 1 dose of Pletaal® SR Capsule during the study period and had follow-up for safety assessment. | 3,365 |
| Total | 3,365 |
Baseline characteristics
| Characteristic | Pletaal® SR Capsule |
|---|---|
| Age, Continuous | 66.27 years STANDARD_DEVIATION 10.92 |
| Sex: Female, Male Female | 1920 Participants |
| Sex: Female, Male Male | 1445 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 372 / 3,365 |
| serious Total, serious adverse events | 74 / 3,365 |
Outcome results
Primary
The Incidence Rate and the Number of AE/ADRs
Incidence rates of overall AEs and ADRs that occurred during the study period
Time frame: Follow-up at least once from baseline to 16 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pletaal® SR Capsule | The Incidence Rate and the Number of AE/ADRs | Number of patients reported for AE | 446 Participants |
| Pletaal® SR Capsule | The Incidence Rate and the Number of AE/ADRs | Number of patients reported for ADR | 155 Participants |
Secondary
The Incidence Rate of Tarchycardia and Palpitation After Pletaal® SR Capsule Administration
Time frame: Follow-up at least once from baseline to 16 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pletaal® SR Capsule | The Incidence Rate of Tarchycardia and Palpitation After Pletaal® SR Capsule Administration | Number of patients reported for 'Tachycardia' | 5 Participants |
| Pletaal® SR Capsule | The Incidence Rate of Tarchycardia and Palpitation After Pletaal® SR Capsule Administration | Number of patients reported for 'Palpitat | 19 Participants |
Secondary
The Number and Percentage of Drop-out Patients According to Aes
Time frame: Follow-up at least once from baseline to 16 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pletaal® SR Capsule | The Number and Percentage of Drop-out Patients According to Aes | 147 Participants |