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Aspirin Resistance and Percutaneous Coronary Intervention (PCI) (RESIST)

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ClinicalTrials.gov Identifier: NCT01103440
Recruitment Status : Completed
First Posted : April 14, 2010
Results First Posted : February 14, 2018
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Annapoorna Kini, Icahn School of Medicine at Mount Sinai

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Stable Angina
Interventions: Drug: Intravenous Glycoprotein inhibitor + ASA, Clopidogrel
Drug: Antiplatelet Therapy (ASA, Clopidogrel)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
330 patients were screened with 36 enrolled between April 2007 and December 2008

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
Conventional Strategy Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure
Aggressive Strategy Patient receive 325mg ASA orally and loading does of 600mg Clopidogrel at time of procedure with addition of IV GP IIb/IIIa inhibitor bolus intra procedurally

Participant Flow:   Overall Study
    Conventional Strategy   Aggressive Strategy
STARTED   18   18 
COMPLETED   18   18 
NOT COMPLETED   0   0 



  Baseline Characteristics

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
Conventional Strategy Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure
Aggressive Strategy Patient receive 325mg ASA orally and loading does of 600mg Clopidogrel at time of procedure with addition of IV GP IIb/IIIa inhibitor bolus intra procedurally
Total Total of all reporting groups

Baseline Measures
   Conventional Strategy   Aggressive Strategy   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   18   36 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.2  (10)   66.2  (9)   65.7  (9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      6  33.3%      6  33.3%      12  33.3% 
Male      12  66.7%      12  66.7%      24  66.7% 


  Outcome Measures

1.  Primary:   Number of Participants With Elevation of Cardiac Enzyme   [ Time Frame: 24 hours ]

2.  Secondary:   Number of Participants With Major Adverse Cardiac Event (MACE)   [ Time Frame: 30 days ]


  Serious Adverse Events


  Other Adverse Events


  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
Small pilot study with a limited sample size and not powered to detect differences in individual ischemic endpoints. Study does not delineate an optimal dose of aspirin. Antiplatelet effect of aspirin may fluctuate in patients at the same dosage.


  More Information

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


Results Point of Contact:  
Name/Title: Dr. Annapoorna S Kini
Organization: Icahn School of Medicine at Mount Sinai
phone: (212) 241-4181
e-mail: Annapoorna.Kini@mountsinai.org



Responsible Party: Annapoorna Kini, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01103440     History of Changes
Other Study ID Numbers: GCO-07-0200
First Submitted: April 12, 2010
First Posted: April 14, 2010
Results First Submitted: January 18, 2018
Results First Posted: February 14, 2018
Last Update Posted: February 14, 2018