Bedside Genetic or Pharmacodynamic Testing to Prevent Periprocedural Myonecrosis During PCI (ONSIDE TEST) (ONSIDE TEST)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01930773|
Recruitment Status : Recruiting
First Posted : August 29, 2013
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stable Angina||Device: Genotyping Device: Phenotyping||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optimal P2Y12-receptor treatmeNt Guided by bedSIDe Genetic or Pharmacodynamic TESTing to Prevent Periprocedural Myonecrosis During Elective Percutaneous Coronary Intervention.|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||May 2018|
Experimental: Genotyping Arm
Rapid genotyping to select optimal P2Y12-inhibitor for PCI.
Patients harboring CYP2C19 *2 alleles receive 60 mg prasugrel for PCI, while non-carriers receive 600 mg clopidogrel if not pretreated with clopidogrel.
Other Name: Spartan rapid genotyping device to screen CYP2C19 *2 carriage in patients in the Genotyping Arm.
Experimental: Phenotying Arm
The use of platelet function testing to select the optimal P2Y12-inhibitor for PCI.
Patients having high on-treatment platelet reactivity (HPR: greater than 208 PRU) receive 60 mg prasugrel loading dose (LD), others continue clopidogrel for PCI.
Other Name: VerifyNow P2Y12 assay to test the response to clopidogrel.
No Intervention: Conventional Arm
Regular approach for performing elective PCI.
- Prevalence of periprocedural myocardial injury within 24 h after PCI [ Time Frame: Within 24 hours after Percutaneous Coronary Intervention (PCI) ]Post-procedural troponin value increase exceeding the 99th percentile upper reference limit (URL) within 24 hours after PCI
- Proportion of patients having periprocedural myocardial infarction (MI) [ Time Frame: Within 24 hours or PCI ]Periprocedural MI is defined as a CK-MB elevation greater than 3x of the upper limit of norm (ULN) within 24 hours of elective PCI.
- Peak troponin elevation [ Time Frame: Within 24 hours of PCI ]The level of peak troponin-I elevation during 24 hours of elective PCI
- Proportion of patients with peri-procedural MI [ Time Frame: Within 24 hours of PCI ]The rate of peri-procedural MI defined as a peak troponin-I value greater than 5x the ULN within 24 hours.
- BARC type 3 and 5 bleeding [ Time Frame: Within 1 week of PCI ]BARC-defined type 3 (clinical, laboratory, and/or imaging evidence of bleeding, with healthcare provider responses) and type 5 (fatal) bleeds happening within 7 days of PCI.
- Death, MI, stent thrombosis (ST) or urgent repeat revascularization [ Time Frame: 30 days after PCI ]The rate of cardiac death, myocardial infarction, definite or probable stent thrombosis or urgent repeat revascularization within 30 days of elective PCI.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01930773
|Contact: Lukasz Koltowski, MD, PhDfirstname.lastname@example.org|
|Contact: Mariusz Tomaniak, MDemail@example.com|
|Heart Center Balatonfüred||Active, not recruiting|
|Balatonfüred, Hungary, 8230|
|1st Department of Cardiology, Medical University of Warsaw||Recruiting|
|Warsaw, Poland, 02-097|
|Contact: Lukasz Koltowski, MD, PhD firstname.lastname@example.org|
|Contact: Mariusz Tomaniak, MD email@example.com|
|Principal Investigator: Lukasz Koltowski, MD|
|Sub-Investigator: Mariusz Tomaniak, MD|