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Does Continued Use of Clopidogrel Into Surgery Cause Increased Perioperative Bleeding?

This study has been completed.
Sponsor:
Collaborator:
Doris Duke Charitable Foundation
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT01960296
First received: October 8, 2013
Last updated: April 28, 2017
Last verified: April 2017
Results First Received: March 17, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition: Clopidogrel
Interventions: Drug: Clopidogrel
Drug: Discontinue Clopidogrel

  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
Participants from 6 institution-affiliated ambulatory general surgery clinics were assessed for eligibility between January 2011 and May 2013.

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
Clopidogrel Continue home dose of clopidogrel into surgery
Discontinue Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.

Participant Flow:   Overall Study
    Clopidogrel   Discontinue
STARTED   23   25 
COMPLETED   21   22 
NOT COMPLETED   2   3 
Postponed surgery                1                0 
Received different procedure                1                3 



  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
Clopidogrel Continue home dose of clopidogrel into surgery
Discontinue Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
Total Total of all reporting groups

Baseline Measures
   Clopidogrel   Discontinue   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   22   43 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.9  (0)   67.9  (0)   67.9  (0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      7  33.3%      9  40.9%      16  37.2% 
Male      14  66.7%      13  59.1%      27  62.8% 
Indication 
[Units: Participants]
     
Coronary stent   18   13   31 
CVA   1   2   3 
Other   2   7   9 
CAD/CVD/PAD [1] 
[Units: Participants]
     
yes   20   18   38 
no   1   4   5 
[1] Coronary Artery Disease(CAD)/Cerebrovascular Disease(CVD)/Peripheral Arterial Disease(PAD)
Hypertension 
[Units: Participants]
     
yes   19   19   38 
no   2   3   5 
Diabetes 
[Units: Participants]
     
yes   12   12   24 
no   9   10   19 
HL 
[Units: Participants]
     
yes   19   20   39 
no   2   2   4 
ASA score [1] 
[Units: Participants]
     
 4   1   5 
>2   17   21   38 
[1] Preoperative American Society of Anesthesia (ASA) scores to evaluate the degree of a patient's "sickness" or "physical state" before selecting the anesthetic or before performing surgery, with one being normal to five being severely impaired.
Normal platelet function 
[Units: Participants]
     
yes   15   16   31 
no   6   6   12 
Aspirin Use 
[Units: Participants]
     
yes   14   18   32 
no   7   4   11 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Bleeding-related Re-hospitalization   [ Time Frame: up to 90 days post op ]

2.  Primary:   Perioperative Bleeding Complications   [ Time Frame: up to 90 days postop ]

3.  Secondary:   Procedure Estimated Blood Loss   [ Time Frame: up to 90 days postop ]

4.  Secondary:   Procedure Time   [ Time Frame: Day 1 ]

5.  Secondary:   Average Change in Hematocrit   [ Time Frame: baseline and Day 1 ]

6.  Secondary:   Average Length of Hospital Stay   [ Time Frame: up to 90 days ]

7.  Secondary:   Same Day Discharged   [ Time Frame: up to 90 days ]

8.  Secondary:   Development of Myocardial Infarction or Thrombosis   [ Time Frame: up to 90 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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 major limitation of the study is its low sample size, making it underpowered to draw unequivocal conclusions.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Celia M. Divino
Organization: Icahn School of Medicine at Mount Sinai
phone: 212-241-5499
e-mail: celia.divino@mountsinai.org


Publications of Results:
Other Publications:

Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01960296     History of Changes
Other Study ID Numbers: GCO 10-1067
Study First Received: October 8, 2013
Results First Received: March 17, 2017
Last Updated: April 28, 2017