Cardiovascular Research

Covenant Cardiology physicians are involved in nationally recognized clinical trials that include cardiovascular devices and drugs to promote cutting edge diagnostic treatments and prevention.

Each clinical trial is supervised by one of the physicians at the site where it is being conducted who is called the Principal Investigator (PI). The PI is ultimately responsible for all medical decisions related to that trial. The PI conducts the trial in compliance with the protocol in conjunction with the sponsor.

Phase 1 Studies

  • The initial introduction of an investigational new drug into humans
  • Closely monitored and may be conducted in patients or normal volunteer subjects
  • Designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and if possible, to gain early evidence of effectiveness
  • Total number of subjects and patients included in phase 1 studies varies with the drug, but is generally in the range of 20 to 80

Phase 2 Studies

  • Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease
  • Determine the common short-term side effects and risks associated with the drug
  • Well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects

Phase 3 Studies

  • Performed after preliminary evidence suggesting effectiveness of the drug has been obtained
  • Gather the additional information about the effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling
  • Include from several hundred to several thousand subjects

Phase 4 Studies

  • Delineate additional information about the drug's risks, benefits, and optimal use
  • Different doses or schedules of administration than were used in phase 2 studies
  • Use of the drug in other patient populations or other stages of the disease
  • Use of the drug over a longer period of time

A list of current cardiovascular clinical trials follows:

Spire 1 & 2

Phase 3 multi-center, double-blind, randomized, placebo-controlled, parallel group evaluation of the efficacy, safety, and tolerability of bococizumab (PF-04950615), in reducing the occurrence of major cardiovascular events in high risk subjects

PI: Dr. Mayar Jundi

Drug class PCSK9. For patients with elevated LDL cholesterol and cardiovascular risk factors.


Dal-GenE

A phase 3, double‐blind, randomized placebo‐controlled study to evaluate the effects of dalcetrapib on cardiovascular (CV) risk in a genetically defined population with a recent acute coronary syndrome (ACS): The Dal‐GenE trial

PI: Dr. Manoj Sharma

Reduction of cardiovascular mortality and morbidity in patients with a recent acute coronary syndrome event and a specific genotype variant


CLIRST

To demonstrate the safety and effectiveness of the SurgWerks - CLI Kit and VXP System for the rapid intra-operative aspiration, preparation and intramuscular injection of concentrated autologous bone marrow cells into the ischemic index limb of Rutherford Category 5 non-reconstructable critical limb ischemia patients

PI: Dr. Firas Alani

Stem cell study for patients with ischemic lower extremities


ARTEMIS

Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study

PI: Dr. Manoj Sharma

Post MI patients are asked to be in this registry study. They are called 4 times by Duke Clinical Research Institute to complete a phone interview.


AUGUSTUS

An open-label, 2 x 2 factorial, randomized controlled, clinical trial to evaluate the safety of Apixaban vs. Vitamin K antagonist and aspirin vs. aspirin placebo in patients with atrial fibrillation and acute coronary syndrome or percutaneous coronary intervention

PI: Dr. Umesh Badami

Patients with acute coronary syndrome (ACS) who receive a PCI and have atrial fibrillation. Upon discharge patients will be randomized to either apixaban or coumadin.


RE-DUAL PCI

A prospective randomized, open label, blinded endpoint (PROBE) 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

PI: Dr. Manoj Sharma

Patients with acute coronary syndrome (ACS) who receive a PCI and have atrial fibrillation. Upon discharge patients will be randomized to either Coumadin or pradaxa.


MARINER

Medically ill patient assessment of rivaroxaban versus placebo in reducing post-discharge venous thrombo-embolism risk

PI: Dr. Umesh Badami

For patients who may need DVT (blood clot) prevention medication upon hospital discharge.


MK8835

Randomized, double-blind, placebo-controlled, parallel-group study to assess cardiovascular outcomes following treatment with ertugliflozin (MK-8835/PF-04971729) in subjects with type 2 diabetes mellitus and established vascular disease

PI: Dr. Firas Alani

For diabetic patients with cardiovascular disease.


STRENGTH

Long-term outcomes study to assess statin residual risk reduction with EpaNova in high cardiovascular risk patients with hypertriglyceridemia (STRENGTH)

PI: Dr. Mayar Jundi

Is a fish oil capsule. For patients with triglycerides >180 & <500.


SCAFFOLD

GORE carotid stent clinical study for the treatment of carotid artery stenosis in patients at increased risk for adverse events from carotid endarterectomy

PI: Dr. Firas Alani

Investigational carotid stent study.


ISCHEMIA

International Study of Comparative Health Effectiveness with Medical and Invasive Approaches: Ischemia is an international comparative effectiveness study. Participants will be recruited following clinically indicated stress testing but before catherization and randomized in a 1:1 fashion to an invasive or conservative strategy.

PI: Dr. Umesh Badami

Patients with moderate to severe Ischemia on stress test will have CCTA, and then be randomized to either cardiac catherization or medical treatment.


CIRT

Cardiovascular Inflammation Reduction Trial: Multicenter, double-blind NIH sponsored study where 7,000 men and women who have suffered an MI and have Type II DM will be randomized to methotrexate or placebo to help determine whether study drug will reduce rates of recurrent MI, stroke, or CV death along with directly testing the inflammatory hypothesis of atherothrombosis.

PI: Dr. Firas Alani

For patients with a MI and have diabetes or metabolic syndrome.


GLORIA AF

Global Registry of Long-term Oral Anti-thrombotic Treatment In Patients with Atrial Fibrillation: International, multicenter, prospective observational study for patients with newly diagnosed non-valvular atrial fibrillation. The Registry Program will be run in three different phases. Phase I is conducted before approval of dabigatran. This protocol describes the two phases after dabigatran is approved for preventing strokes in patients with atrial fibrillation (SPAF) in participating countries (Phases II and III) The phases differ regarding the handling of the follow-up period. In Phase II (after the approval of dabigatran) there will be a cross-sectional analysis at the patient’s baseline visit for all patients and a follow-up for two years for patients initially treated with dabigatran. In Phase III (given the comparability of the patient population prescribed either dabigatran or vitamin K-antagonists) new patient recruitment will be started and after the baseline visit all patients will be followed up for three years regardless of antithrombotic therapy treatment status. The baseline visit is defined as the physical visit when the patient is enrolled in the registry. Patients will either participate in Phase II or Phase III.

PI: Dr. Mayar Jundi

For patients with newly diagnosed AF (< 3 months) on either Coumadin or Pradaxa.