Efficacy of Long Term Plavix Therapy Post Angioplasty

Percutaneous Coronary Intervention Clinical Trial

Official title:

Evaluation of Safety, Benefits and Complications of Long-term Dual Antiplatelet Therapy in Patients With Angioplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02327741
• Other study ID #: 90-2348
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: October 2014

Study information

• Verified date: April 2020
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1010
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Percutaneous Coronary Intervention

Intervention

Drug:
• plavix
taking plavix more than 12 months
• plavix
taking plavix less than 12 months

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences	Baqiyatallah university of medical sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Major Bleeding Need Transfusion	number of patients with major bleeding need transfusion	12 months
Primary	Number of Patients With Myocardial Infarction Need Hospital Admission	The number of patients with myocardial infarction need hospital admission	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	12 months
Primary	Number of Patients With Death Due to Cardiac Causes	the number patients with death due to cardiac causes	12 months
Primary	Revascularization - Need for Redo Bypass Surgery and Redo Angioplasty	need for redo bypass surgery and redo angioplasty	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	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	12 months