Trial Outcomes & Findings for Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Registry (NCT NCT01515345)

NCT ID: NCT01515345

Last Updated: 2017-04-25

Results Overview

The angiographic or pathological confirmation of stent thrombosis is called "definite stent thrombosis"

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1008 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2017-04-25

Participant Flow

all consecutive PCI patients with stent implantation or drug eluting balloon dilation in our institution until June 2012

Participant milestones

Measure	Standard Therapy standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)	Individualized Therapy dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
Overall Study STARTED	665	343
Overall Study COMPLETED	664	343
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Registry

Baseline characteristics by cohort

Measure	Standard Therapy n=665 Participants standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)	Individualized Therapy n=343 Participants dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer	Total n=1008 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	333 Participants n=5 Participants	169 Participants n=7 Participants	502 Participants n=5 Participants
Age, Categorical >=65 years	332 Participants n=5 Participants	174 Participants n=7 Participants	506 Participants n=5 Participants
Age, Continuous	65 years STANDARD_DEVIATION 12 • n=5 Participants	64 years STANDARD_DEVIATION 12 • n=7 Participants	65 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	183 Participants n=5 Participants	120 Participants n=7 Participants	303 Participants n=5 Participants
Sex: Female, Male Male	482 Participants n=5 Participants	223 Participants n=7 Participants	705 Participants n=5 Participants
Region of Enrollment Austria	665 participants n=5 Participants	343 participants n=7 Participants	1008 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

The angiographic or pathological confirmation of stent thrombosis is called "definite stent thrombosis"

Outcome measures

Measure	Standard Therapy n=664 Participants standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)	Individualized Therapy n=343 Participants dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
Definite Stent Thrombosis	1 participants	0 participants

PRIMARY outcome

Timeframe: 30days

Bleeding classified by the TIMI hemorrhage classification scheme:

Minor: any clinically overt sign of hemorrhage (including imaging) that is associated with a hemoglobin drop of 3 to < 5 g/dL

Major: (1) if it is intracranial, or (2) clinically significant overt signs of hemorrhage associated with a drop inhemoglobin of > 5 g/dL

Outcome measures

Measure	Standard Therapy n=664 Participants standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)	Individualized Therapy n=343 Participants dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
Any Bleeding Event	17 participants	9 participants

SECONDARY outcome

Timeframe: 30days

Probable stent thrombosis is considered to have occurred in case of

1. any unexplained death within the first 30 days.

2. any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause, irrespective of the time after the index procedure

Outcome measures

Measure	Standard Therapy n=664 Participants standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)	Individualized Therapy n=343 Participants dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
Probable Stent Thrombosis	2 participants	0 participants

Adverse Events

Standard Therapy

Serious events: 26 serious events

Other events: 0 other events

Deaths: 0 deaths

Individualized Therapy

Serious events: 18 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Standard Therapy n=664 participants at risk standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)	Individualized Therapy n=343 participants at risk dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
Cardiac disorders Definite stentthrombosis	0.15% 1/664 • Number of events 1 it was not intended to collect adverse events, other than SAEs	0.00% 0/343 it was not intended to collect adverse events, other than SAEs
Cardiac disorders probable Stentthrombosis	0.30% 2/664 • Number of events 2 it was not intended to collect adverse events, other than SAEs	0.00% 0/343 it was not intended to collect adverse events, other than SAEs
Cardiac disorders Cardiovascular death	0.90% 6/664 • Number of events 6 it was not intended to collect adverse events, other than SAEs	2.6% 9/343 • Number of events 9 it was not intended to collect adverse events, other than SAEs
Cardiac disorders Bleeding (TIMI major)	0.90% 6/664 • Number of events 6 it was not intended to collect adverse events, other than SAEs	1.2% 4/343 • Number of events 4 it was not intended to collect adverse events, other than SAEs
Cardiac disorders Bleeding (TIMI minor)	1.7% 11/664 • Number of events 11 it was not intended to collect adverse events, other than SAEs	1.5% 5/343 • Number of events 5 it was not intended to collect adverse events, other than SAEs

Other adverse events

Adverse event data not reported

Additional Information

Univ.Prof. Dr Günter Christ

Kaiser Franz Josef Hospital

Phone: +43160191

Email: guenter.christ@wienkav.at

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place