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| Name | Class |
|---|---|
| Baqiyatallah Medical Sciences University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| plavix long term | Experimental | taking plavix more than 12 months |
|
| plavix short term | Active Comparator | taking plavix less than 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| plavix | Drug | taking plavix more than 12 months |
| |
| plavix |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Major Bleeding Need Transfusion | number of patients with major bleeding need transfusion | 12 months |
| Number of Patients With Myocardial Infarction Need Hospital Admission | The number of patients with myocardial infarction need hospital admission | 12 month |
| 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 | 12 months |
| Number of Patients With Death Due to Cardiac Causes | the number patients with death due to cardiac causes | 12 months |
| Revascularization - Need for Redo Bypass Surgery and Redo Angioplasty | need for redo bypass surgery and redo angioplasty | 12 months |
| Number of Patients With Minor Bleeding | the number of patients with petechiae and superficial ecchymosis or nose bleeding need no admission or drug changes | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| javad kojuri, M.D. M.S. | shiraz university of medcal sciences | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Plavix Short Term | taking plavix less than 12 months plavix: taking plavix less than 12 months |
| FG001 | Plavix Long Term | taking plavix more than 12 months plavix: taking plavix more than 12 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Plavix Long Term | taking plavix more than 12 months plavix: taking plavix more than 12 months |
| BG001 | Plavix Short Term | taking plavix less than 12 months plavix: taking plavix less than 12 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Major Bleeding Need Transfusion | number of patients with major bleeding need transfusion | Posted | Count of Participants | Participants | 12 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Plavix Short Term | taking plavix less than 12 months | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bleeding | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| minor bleeding | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor | shiraz university of medical sciences | 009836250352 | kojurij@yahoo.com |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Drug |
taking plavix less than 12 months |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| type of stents | Count of Participants | Participants |
|
| coronary risk factors | Count of Participants | Participants |
|
| which coronary vessel involved | Count of Participants | Participants |
|
|
|
| Primary | Number of Patients With Myocardial Infarction Need Hospital Admission | The number of patients with myocardial infarction need hospital admission | Posted | Count of Participants | Participants | 12 month |
|
|
|
| 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 | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Primary | Number of Patients With Death Due to Cardiac Causes | the number patients with death due to cardiac causes | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Primary | Revascularization - Need for Redo Bypass Surgery and Redo Angioplasty | need for redo bypass surgery and redo angioplasty | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 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 | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 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 | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 502 |
| 20 |
| 502 |
| 13 |
| 502 |
| EG001 | Plavix Long Term | taking plavix more than 12 months | 1 | 508 | 14 | 508 | 4 | 508 |
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| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |