Trial Outcomes & Findings for Aspirin Resistance and Percutaneous Coronary Intervention (PCI) (NCT NCT01103440)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

36 participants

Primary outcome timeframe

24 hours

Results posted on

2018-02-14

Participant Flow

330 patients were screened with 36 enrolled between April 2007 and December 2008

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	18	18
Overall Study COMPLETED	18	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aspirin Resistance and Percutaneous Coronary Intervention (PCI)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Conventional Strategy n=18 Participants Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure	Aggressive Strategy n=18 Participants 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 n=36 Participants Total of all reporting groups
Age, Continuous	65.2 years STANDARD_DEVIATION 10 • n=5 Participants	66.2 years STANDARD_DEVIATION 9 • n=7 Participants	65.7 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

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.

Outcome measures

Outcome measures
Measure	Conventional Strategy n=18 Participants Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure	Aggressive Strategy n=18 Participants 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
Number of Participants With Elevation of Cardiac Enzyme	4 Participants	2 Participants

SECONDARY outcome

Timeframe: 30 days

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.

Outcome measures

Outcome measures
Measure	Conventional Strategy n=18 Participants Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure	Aggressive Strategy n=18 Participants 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
Number of Participants With Major Adverse Cardiac Event (MACE)	5 Participants	1 Participants

Adverse Events

Conventional Strategy

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Aggressive Strategy

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Conventional Strategy n=18 participants at risk Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure	Aggressive Strategy n=18 participants at risk 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
Cardiac disorders Stent thrombosis	11.1% 2/18	0.00% 0/18
Cardiac disorders Urgent Vascularization	11.1% 2/18	0.00% 0/18
Cardiac disorders Myocardial Infarction	11.1% 2/18	0.00% 0/18
Blood and lymphatic system disorders Major Bleeding	5.6% 1/18	0.00% 0/18
Blood and lymphatic system disorders Minor Bleeding	11.1% 2/18	5.6% 1/18
Cardiac disorders Cardiac Enzyme Elevation: Troponin-I	22.2% 4/18	11.1% 2/18
Cardiac disorders Cardiac Enzyme Elevation: CK-MB	11.1% 2/18	5.6% 1/18

Additional Information

Dr. Annapoorna S Kini

Icahn School of Medicine at Mount Sinai

Phone: (212) 241-4181

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place