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Trial record 27 of 27 for:    cangrelor

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)
Enrollment 36
Recruitment Details 330 patients were screened with 36 enrolled between April 2007 and December 2008
Pre-assignment Details  
Arm/Group Title Conventional Strategy Aggressive Strategy
Hide Arm/Group Description Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure 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
Period Title: Overall Study
Started 18 18
Completed 18 18
Not Completed 0 0
Arm/Group Title Conventional Strategy Aggressive Strategy Total
Hide Arm/Group Description Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure 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 of all reporting groups
Overall Number of Baseline Participants 18 18 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 18 participants 36 participants
65.2  (10) 66.2  (9) 65.7  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
Female
6
  33.3%
6
  33.3%
12
  33.3%
Male
12
  66.7%
12
  66.7%
24
  66.7%
1.Primary Outcome
Title Number of Participants With Elevation of Cardiac Enzyme
Hide Description Number of participants with peri-procedural biomarker elevation defined as any elevation above baseline of CK-MB or Tn-I within 24 hours after completion of the procedure.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conventional Strategy Aggressive Strategy
Hide Arm/Group Description:
Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure
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
Overall Number of Participants Analyzed 18 18
Measure Type: Count of Participants
Unit of Measure: Participants
4
  22.2%
2
  11.1%
2.Secondary Outcome
Title Number of Participants With Major Adverse Cardiac Event (MACE)
Hide Description Number of participants with MACE which is any event of Death, MI, Stent Thrombosis, Urgent Revascularization, Bleeding. Major adverse cardiac events (MACE), defined as the composite of death, MI (CK-MB > 3 times normal), urgent revascularization and definite or probable stent thrombosis (ST) within 30 days. Stent thrombosis was defined according to the new academic research consortium definitions; 2) bleeding complications within 30 days. Major bleeding was defined as intracranial or intraocular bleeding or a drop in hemoglobin > 5 g/dL. Minor bleeding was defined as hemorrhage at the access site requiring intervention, hematoma with a diameter of at least 5 cm, a reduction in hemoglobin levels of at least 4 g/dL without an overt bleeding source or at least 3 g/dL with such a source, reoperation for bleeding or transfusion of a blood product.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conventional Strategy Aggressive Strategy
Hide Arm/Group Description:
Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure
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
Overall Number of Participants Analyzed 18 18
Measure Type: Count of Participants
Unit of Measure: Participants
5
  27.8%
1
   5.6%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Conventional Strategy Aggressive Strategy
Hide Arm/Group Description Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure 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
All-Cause Mortality
Conventional Strategy Aggressive Strategy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Conventional Strategy Aggressive Strategy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Conventional Strategy Aggressive Strategy
Affected / at Risk (%) Affected / at Risk (%)
Total   15/18 (83.33%)   4/18 (22.22%) 
Blood and lymphatic system disorders     
Major Bleeding  1/18 (5.56%)  0/18 (0.00%) 
Minor Bleeding  2/18 (11.11%)  1/18 (5.56%) 
Cardiac disorders     
Stent thrombosis  2/18 (11.11%)  0/18 (0.00%) 
Urgent Vascularization  2/18 (11.11%)  0/18 (0.00%) 
Myocardial Infarction  2/18 (11.11%)  0/18 (0.00%) 
Cardiac Enzyme Elevation: Troponin-I  4/18 (22.22%)  2/18 (11.11%) 
Cardiac Enzyme Elevation: CK-MB  2/18 (11.11%)  1/18 (5.56%) 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Annapoorna S Kini
Organization: Icahn School of Medicine at Mount Sinai
Phone: (212) 241-4181
EMail: Annapoorna.Kini@mountsinai.org
Layout table for additonal information
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