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OpenTrials
Completed

NCT Number: NCT02327741

Efficacy of Long Term Plavix Therapy Post Angioplasty

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.

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Key information

Conditions

Percutaneous Coronary Intervention

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plavix

Drug

taking plavix more than 12 months

Primary outcomes

  1. Number of Patients With Major Bleeding Need Transfusion

    Time frame: 12 months

    number of patients with major bleeding need transfusion

  2. Number of Patients With Myocardial Infarction Need Hospital Admission

    Time frame: 12 month

    The number of patients with myocardial infarction need hospital admission

  3. Number of Patients With Central Vascular Accidents Proved by CT Scan

    Time frame: 12 months

    the number of patients with major vascular brain accidents ( CVA) proved by CT scan

  4. Number of Patients With Death Due to Cardiac Causes

    Time frame: 12 months

    the number patients with death due to cardiac causes

  5. Revascularization - Need for Redo Bypass Surgery and Redo Angioplasty

    Time frame: 12 months

    need for redo bypass surgery and redo angioplasty

  6. Number of Patients With Minor Bleeding

    Time frame: 12 months

    the number of patients with petechiae and superficial ecchymosis or nose bleeding need no admission or drug changes

Secondary outcomes

  1. Tolerability - the Number of Patients , Who Are Able to Take Plavix Concerning Compliance and Economic Issues

    Time frame: 12 months

    the number of patients who are able to take plavix concerning compliance and economic issues

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Collaborators

  • Baqiyatallah Medical Sciences University

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 30, 2014
Registry last updated
Apr 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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