(A Novel Pharmacologic Regime for Elective Percutaneous Coronary Intervention) (REDUCED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hasan ARI, Bursa Postgraduate Hospital
ClinicalTrials.gov Identifier:
NCT01031095
First received: December 11, 2009
Last updated: December 24, 2013
Last verified: December 2013
Results First Received: January 21, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Intervention: Other: coronary intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Low Dose Intracoronary Heparin Low dose intracoronary heparin treatment arm
Standard Therapy standard unfractionated heparin (UFH) treatment

Participant Flow:   Overall Study
    Low Dose Intracoronary Heparin     Standard Therapy  
STARTED     100     100  
COMPLETED     100     100  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Low Dose Intracoronary Heparin Low dose intracoronary heparin treatment arm
Standard Therapy standard UFH treatment
Total Total of all reporting groups

Baseline Measures
    Low Dose Intracoronary Heparin     Standard Therapy     Total  
Number of Participants  
[units: participants]
  100     100     200  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     80     80     160  
>=65 years     20     20     40  
Age  
[units: years]
Mean ± Standard Deviation
  59.11  ± 9.68     58.99  ± 11.24     59.06  ± 10.46  
Gender  
[units: participants]
     
Female     25     19     44  
Male     75     81     156  
Region of Enrollment  
[units: participants]
     
Turkey     100     100     200  



  Outcome Measures
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1.  Primary:   Major Adverse Cardiac Events   [ Time Frame: 30 days ]

2.  Primary:   Major Adverse Cardiac Event   [ Time Frame: 30 days ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The intraprocedural use of a heparinised flush was not controlled; however, given the maximum amount that was allowed to be used, this is not likely to have significantly affected the activated clotting times. .  


Results Point of Contact:  
Name/Title: Dr.Hasan ARI
Organization: Bursa Postgraduate Hospital
phone: 00902243605050 ext 1739
e-mail: hasanari03@yahoo.com


Publications:

Responsible Party: Hasan ARI, Bursa Postgraduate Hospital
ClinicalTrials.gov Identifier: NCT01031095     History of Changes
Other Study ID Numbers: BYİEAH1
Study First Received: December 11, 2009
Results First Received: January 21, 2012
Last Updated: December 24, 2013
Health Authority: Turkey: Ethics Committee