Efficacy of Long Term Plavix Therapy Post Angioplasty

NCT02327741 | Completed Results

• 1 other identifier: 90-2348
• Study Type: interventional
• Target: 1,010
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Percutaneous Coronary Intervention

Keywords

Dual antiplatelet therapy; clopidogrel; percutaneous coronary intervention

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (1)

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

  12 months

Study Arms (2)

plavix long term

EXPERIMENTAL

taking plavix more than 12 months

Drug: plavix

plavix short term

ACTIVE COMPARATOR

taking plavix less than 12 months

Drug: plavix

Interventions

plavix DRUG

taking plavix more than 12 months

plavix long term

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• post stent ( lesion more than 70% and vessel more than 2.25 mm )

You may not qualify if:

• 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

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead
• Baqiyatallah Medical Sciences University: collaborator

MeSH Terms

Interventions

Clopidogrel

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Professor
• Organization: shiraz university of medical sciences

kojurij@yahoo.com

009836250352

Study Officials

• javad kojuri, M.D. M.S.

  shiraz university of medcal sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 13, 2014
• First Posted: December 30, 2014
• Study Start: October 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 29, 2020
• Results First Posted: April 29, 2020

Record last verified: 2020-04