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Interventional Studies

ARTEMIS
Copayment coverage of ticagrelor/clopidogrel for STEMI/NSTEMI patients to evaluate if copayment reduction significantly influences antiplatelet therapy selection and long-term adherence. In addition, this study evaluates patient outcomes and the overall cost of care after AMI.

Inclusion criteria:

  1. Age ≥ 18 years at screening
  2. Have been diagnosed with STEMI or NSTEMI during the index hospitalization
  3. Are treated with a P2Y12 receptor inhibitor at the time of enrollment
  4. Have United States-based health insurance coverage with prescription drug benefit
  5. No prior intracranial hemorrhage

Identification: Inpatient

ABSORB IV
Evaluating the safety and effectiveness of Absorb Bioresorbable Vascular Scaffold to the commercially approved XIENCE.

Inclusion criteria:

  1. Age ≥ 18 years at screening
  2. Evidence of myocardial ischemia.
    Patients with stable coronary syndromes can be enrolled any time after symptom onset. Patients with acute coronary syndrome may be enrolled under the following conditions: unstable angina or NSTEMI within 2 weeks of the index procedure OR STEMI > 72 weeks ≤ 2 weeks prior to the index procedure.
  3. Must be suitable for PCI.
    Subjects with stable angina or silent ischemia and < 70% diameter stenosis must have objective signs of ischemia (determined by abnormal stress echocardiogram, nuclear scan, ECG, PET, MRI, and/or FFR)
  4. Must be suitable for CABG surgery
  5. LVEF ≥ 30%
  6. Angio criteria needs to be fulfilled (not ostial, not LMCA, no large bifurcations, up to two lesions per vessel and up to two vessels)

Identification: Inpatient
Intervention: Inpatient

Silver-AMI
To identify risk factors for all-cause hospital readmission, mortality and decline in health status following hospitalization for AMI among older persons and develop and validate risk stratification tools for hospital readmission, mortality and decline in health status following hospitalization for AMI among older persons.

Inclusion criteria:

  1. Age ≥75 years at screening
  2. Elevation of cardiac markers within 24 hours of presentation to the hospital
  3. Troponin must rise above the upper limit of normal
  4. One of the following:
    Symptoms of ischemia-pain in chest, epigastrium, jaw, or arm, lasting 20 minutes or longer. May be accompanied by dyspnea, diaphoresis, nausea, or syncope OR ECG with ischemic changes (ST elevation, ST depression, T wave inversion in the absence of Left Ventricular Hypertrophy), new LBBB, pathological Q waves) OR imaging evidence of infarction OR intracoronary thrombus on angiography
  5. Any transferred patients must have had a length of stay shorter than 48 hours at the referring hospital

Identification: Inpatient

Re-Dual PCI
A prospective randomized, open label, blinded endpoint study to evaluate dual antithrombotic therapy with dabigatran etexilate (110mg and 150mg b.i.d.) plus clopidogrel or ticagrelor vs. triple therapy strategy with warfarin (INR 2.0-3.0) plus clopidogrel or ticagrelor and aspirin in patients with non valvular atrial fibrillation (NVAF) that have undergone a percutaneous coronary intervention (PCI) with stenting.

Inclusion criteria:

  1. Age ≥ 18
  2. NVAF with oral anticoagulant treatment (either with warfarin, another VKA or other novel oral anticoagulant) or treatment naïve prior to PCI.
    AF may be paroxysmal, persistent or permanent, and not secondary to a reversible disorder such as MI, pulmonary embolism, recent surgery, pericarditis or thyrotoxicosis, unless long term oral anticoagulation is planned
  3. Presenting with an ACS that was successfully treated with PCI and stenting (either BMS or DES) OR stable coronary artery disease with at least one lesion eligible for PCI that was successfully treated by elective PCI and stenting (BMS or DES)
  4. The patient must be willing to and consent to providing a blood sample for CYP2C19 genotyping

Identification: Inpatient