Percutaneous Coronary Intervention
Conditions
Keywords
Dual antiplatelet therapy, clopidogrel, percutaneous coronary intervention
Brief summary
1010 patients post stenting were enrolled to receive Plavix more than 12 months and less than that and rate of bleeding, complication and major cardiovascular adverse events ( MACE) were compared to evaluate safety and feasibility of long term Plavix therapy post stenting.
Detailed description
1010 patients from registry of angioplasty and stenting in Shiraz and Baghiatolah hospital were enrolled and long term Plavix therapy more than and less than 12 months were compared between two groups of patients prospectively and rate of major adverse cardiovascular events ( MACE) (death, myocardial infarction, cerebrovascular accidents and revascularization) and rate of bleeding were compared between 2 groups.Syntax score and American heart association ( AHA) score of coronary involvement were measured and MACE was compared to these scores.
Interventions
DRUGplavix
taking plavix more than 12 months
Sponsors
Baqiyatallah Medical Sciences University
Shiraz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* post stent ( lesion more than 70% and vessel more than 2.25 mm )
Exclusion criteria
* allergy to acetylsalicylic acid or clopidogrel, * planned surgery within 24 months of percutaneous coronary intervention unless the dual antiplatelet therapy could be maintained throughout the perisurgical period * history of bleeding diathesis * major surgery within 15 days * active bleeding * previous stroke in the past 6 months * concomitant or foreseeable need for oral anticoagulation therapy * pregnancy, life expectancy \<24 months, participation in another trial * inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Central Vascular Accidents Proved by CT Scan | 12 months | the number of patients with major vascular brain accidents ( CVA) proved by CT scan |
| Number of Patients With Major Bleeding Need Transfusion | 12 months | number of patients with major bleeding need transfusion |
| Number of Patients With Myocardial Infarction Need Hospital Admission | 12 month | The number of patients with myocardial infarction need hospital admission |
| Number of Patients With Minor Bleeding | 12 months | the number of patients with petechiae and superficial ecchymosis or nose bleeding need no admission or drug changes |
| Number of Patients With Death Due to Cardiac Causes | 12 months | the number patients with death due to cardiac causes |
| Revascularization - Need for Redo Bypass Surgery and Redo Angioplasty | 12 months | need for redo bypass surgery and redo angioplasty |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability - the Number of Patients , Who Are Able to Take Plavix Concerning Compliance and Economic Issues | 12 months | the number of patients who are able to take plavix concerning compliance and economic issues |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Plavix Long Term taking plavix more than 12 months
plavix: taking plavix more than 12 months | 508 |
| Plavix Short Term taking plavix less than 12 months
plavix: taking plavix less than 12 months | 502 |
| Total | 1,010 |
Baseline characteristics
| Characteristic | Total | Plavix Long Term | Plavix Short Term |
|---|---|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 10 | 60 years STANDARD_DEVIATION 10 | 60.1 years STANDARD_DEVIATION 10 |
| coronary risk factors | 707 Participants | 356 Participants | 351 Participants |
| Sex: Female, Male Female | 364 Participants | 184 Participants | 180 Participants |
| Sex: Female, Male Male | 646 Participants | 324 Participants | 322 Participants |
| type of stents drug eluting stents | 655 Participants | 328 Participants | 327 Participants |
| type of stents metallic stents | 355 Participants | 180 Participants | 175 Participants |
| which coronary vessel involved LAD( left anterior descending) | 792 Participants | 392 Participants | 400 Participants |
| which coronary vessel involved LCX ( left circumflex) | 158 Participants | 78 Participants | 80 Participants |
| which coronary vessel involved RCA ( right coronary artery) | 60 Participants | 38 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 502 | 1 / 508 |
| other Total, other adverse events | 13 / 502 | 4 / 508 |
| serious Total, serious adverse events | 20 / 502 | 14 / 508 |
Outcome results
Primary
Number of Patients With Central Vascular Accidents Proved by CT Scan
the number of patients with major vascular brain accidents ( CVA) proved by CT scan
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plavix Short Term | Number of Patients With Central Vascular Accidents Proved by CT Scan | 0 Participants |
| Plavix Long Term | Number of Patients With Central Vascular Accidents Proved by CT Scan | 1 Participants |
Primary
Number of Patients With Death Due to Cardiac Causes
the number patients with death due to cardiac causes
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plavix Short Term | Number of Patients With Death Due to Cardiac Causes | 0 Participants |
| Plavix Long Term | Number of Patients With Death Due to Cardiac Causes | 0 Participants |
Primary
Number of Patients With Major Bleeding Need Transfusion
number of patients with major bleeding need transfusion
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plavix Short Term | Number of Patients With Major Bleeding Need Transfusion | 7 Participants |
| Plavix Long Term | Number of Patients With Major Bleeding Need Transfusion | 10 Participants |
Primary
Number of Patients With Minor Bleeding
the number of patients with petechiae and superficial ecchymosis or nose bleeding need no admission or drug changes
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plavix Short Term | Number of Patients With Minor Bleeding | 13 Participants |
| Plavix Long Term | Number of Patients With Minor Bleeding | 4 Participants |
Primary
Number of Patients With Myocardial Infarction Need Hospital Admission
The number of patients with myocardial infarction need hospital admission
Time frame: 12 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plavix Short Term | Number of Patients With Myocardial Infarction Need Hospital Admission | 5 Participants |
| Plavix Long Term | Number of Patients With Myocardial Infarction Need Hospital Admission | 7 Participants |
Primary
Revascularization - Need for Redo Bypass Surgery and Redo Angioplasty
need for redo bypass surgery and redo angioplasty
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plavix Short Term | Revascularization - Need for Redo Bypass Surgery and Redo Angioplasty | 15 Participants |
| Plavix Long Term | Revascularization - Need for Redo Bypass Surgery and Redo Angioplasty | 14 Participants |
Secondary
Tolerability - the Number of Patients , Who Are Able to Take Plavix Concerning Compliance and Economic Issues
the number of patients who are able to take plavix concerning compliance and economic issues
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plavix Short Term | Tolerability - the Number of Patients , Who Are Able to Take Plavix Concerning Compliance and Economic Issues | 500 Participants |
| Plavix Long Term | Tolerability - the Number of Patients , Who Are Able to Take Plavix Concerning Compliance and Economic Issues | 506 Participants |